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Evaluation of a wireless, portable, wearable multi-parameter vital signs monitor in hospitalized neurological and neurosurgical patients

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  • Sotera Digital health

Abstract

Unrecognized changes in patients’ vital signs can result in preventable deaths in hospitalized patients. Few publications or studies instituting routine patient monitoring have described implementation and the setting of alarm parameters for vital signs. We wanted to determine if continuous multi-parameter patient monitoring can be accomplished with an alarm rate that is acceptable to hospital floor nurses and to compare the rate of patient deterioration events to those observed with routine vital sign monitoring. We conducted a prospective, observational, 5-month pilot study in a 26-bed adult, neurological/neurosurgical unit (non-ICU) in an academic medical center. A patient surveillance system employing a wireless body-worn vital signs monitor with automated nursing notification of alarms via smartphones was used to gather data. Data collected included: alarm rates, rapid response team (RRT) calls, intensive care unit (ICU) transfers, and unplanned deaths before and during the pilot study. Average alarm rate for all alarms (SpO2, HR, RR, NIBP) was 2.3 alarms/patient/day. The RRT call rate was significantly reduced (p < 0.05) from 189 to 158 per 1000 discharges. ICU transfers per 1000 discharges were insignificantly reduced from 53 to 40 compared to the previous 5-month period in the same unit. Similar measures of comparison units did not change over the same period. Although unplanned patient deaths in the study unit were also reduced during the intervention period, this was not statistically significant. Continual, multi-parameter vital signs monitoring can be customized to reduce a high alarm rates, and may reduce rapid response team calls.
Vol.:(0123456789)
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Journal of Clinical Monitoring and Computing
https://doi.org/10.1007/s10877-017-0085-0
ORIGINAL RESEARCH
Evaluation ofawireless, portable, wearable multi-parameter vital
signs monitor inhospitalized neurological andneurosurgical patients
RobertS.Weller1· KristinaL.Foard2· TimothyN.Harwood1,3
Received: 12 January 2017 / Accepted: 28 November 2017
© Springer Science+Business Media B.V., part of Springer Nature 2017
Abstract
Unrecognized changes in patients’ vital signs can result in preventable deaths in hospitalized patients. Few publications or
studies instituting routine patient monitoring have described implementation and the setting of alarm parameters for vital
signs. We wanted to determine if continuous multi-parameter patient monitoring can be accomplished with an alarm rate
that is acceptable to hospital floor nurses and to compare the rate of patient deterioration events to those observed with rou-
tine vital sign monitoring. We conducted a prospective, observational, 5-month pilot study in a 26-bed adult, neurological/
neurosurgical unit (non-ICU) in an academic medical center. A patient surveillance system employing a wireless body-worn
vital signs monitor with automated nursing notification of alarms via smartphones was used to gather data. Data collected
included: alarm rates, rapid response team (RRT) calls, intensive care unit (ICU) transfers, and unplanned deaths before
and during the pilot study. Average alarm rate for all alarms (SpO2, HR, RR, NIBP) was 2.3 alarms/patient/day. The RRT
call rate was significantly reduced (p < 0.05) from 189 to 158 per 1000 discharges. ICU transfers per 1000 discharges were
insignificantly reduced from 53 to 40 compared to the previous 5-month period in the same unit. Similar measures of com-
parison units did not change over the same period. Although unplanned patient deaths in the study unit were also reduced
during the intervention period, this was not statistically significant. Continual, multi-parameter vital signs monitoring can
be customized to reduce a high alarm rates, and may reduce rapid response team calls.
Keywords Critical care· Deterioration· Early warning score· Electronic health records· Patient safety· Physiologic
monitoring
1 Introduction
Historically, the major focus on reducing perioperative mor-
bidity and mortality has been on identifying and reducing
risk factors for anesthesia and surgery. Much less empha-
sis has been placed on elucidating risks during the post-
operative period. One method in which to determine signs
of adverse events in the hospitalized patient, including the
postoperative patient, has been collection, recording, and
tracking of vital signs (VS) data. Traditionally, this infor-
mation is thought to be of great importance in detecting
deterioration and monitoring inpatient medical conditions.
The standard VS [temperature, heart rate (HR), blood pres-
sure (BP), and respiratory rate (RR)] and oxygen satura-
tion (SpO2) are routinely but infrequently recorded outside
of critical care areas. Continuous monitoring on a general
medical-surgical unit may be associated with a decrease in
total length of stay in both hospital and intensive care unit
days, as well as a lower incidence of cardiac arrest [1].
On the other hand, manually entered pulse oximetry data
may not truly reflect more granular, continuous pulse oxi-
metry data that can be automatically captured on the gen-
eral care floor [2]. It seems likely that serious postoperative
cardiopulmonary complications may also be preceded by
changes in HR, BP, and/or RR [3]. We therefore set out to
evaluate a patient surveillance system based on continual
monitoring of pulse oximetry, HR, RR, and non-invasive
* Timothy N. Harwood
tharwood@wakehealth.edu
1 Department ofAnesthesiology, Wake Forest
University School ofMedicine, Medical Center Blvd.,
Winston-Salem27157-1009, NC, USA
2 Department ofNursing, North Carolina Baptist Hospital,
Winston-Salem, NC, USA
3 Department ofAnesthesiology, Wake Forest University
School ofMedicine, Medical Center Boulevard,
Winston-Salem, NC27157-1009, USA
Journal of Clinical Monitoring and Computing
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blood pressure (NIBP) that employs direct nursing notifica-
tion of violation of alarm limits via a wireless phone.
A previous study demonstrated the benefit of continual,
multi-parameter VS monitoring in general non-ICU patients
[4]. One of the concerns about implementing multi-param-
eter continual VS monitoring on a general medical or med-
ical-surgical unit is alarm fatigue. The high rate of alarms,
and their sometimes limited clinical relevance has been well
documented in the operating room (OR) [5] and intensive
care unit (ICU) [6, 7], and the concern about alarm fatigue
is real [5, 6, 8]. In a large study in both the ICU and general
medicine ward of a major children’s medical center, investi-
gators determined that most alarms were non-actionable, and
response time increased as non-actionable alarm exposure
increased [7]. Alarm fatigue could explain these findings. In
general medical units, the nurse to patient ratio is lower than
in the OR and ICU, so continual monitoring in this environ-
ment has the potential for creating a significant burden on
nurses.
The alarm limits used for continual monitoring on the
general care floor may be different than alarm rates used in
OR and ICU settings. Alarm limits in the OR are appropri-
ate in a 1:1 procedure care setting when a provider’s full
attention can be directed to identifying and responding to
legitimately dangerous conditions. However, in a general
care setting with a 1:5 nurse to patient ratio, an alarm redi-
rects nurse attention from other important tasks, and a high
frequency of alarms will desensitize staff, potentially leading
to delayed responses. One approach to reduce the number of
non-actionable alarms is to combine alarm thresholds with
annunciation delays (a delay between when an alarm thresh-
old has been crossed and when the monitor and network alert
is sounded or displayed) [3, 913]. This approach, based
on examining the distribution of VS measurements in the
general floor patient population, has been shown to have
the potential to minimize the alarm rate during continual,
multi-parameter VS monitoring [14].
Because of what we perceived were medication-related
respiratory and cardiac arrests occurring in some of our
non-ICU hospital units, one of the anesthesiologists (RW)
was assigned to oversee these adverse events and consider
monitoring interventions. After a review of several moni-
toring systems, we asked for demonstrations of VS alert
systems (VSAS) from two different companies. After the
demonstrations, we chose to deploy the Sotera VisiMobile
system in a short-term lease arrangement. Implementation
costs were borne primarily from hospital clinical equipment
and nursing education budgets. Sotera did provide technical
assistance in establishing wireless network communication
between their portable monitoring devices, their server, and
our electronic health record system.
We wished to evaluate two hypotheses: (1) using an
automated VSAS monitoring multiple VS would allow us
to “titrate” the VS settings (VS parameter and time) that
triggered alarms and alerted the nursing staff, and (2) use
of an electronic system would help reduce RRT calls and
ICU transfers. We then established a study of an electronic,
automated VS monitoring system in one nursing unit during
an evaluation of several networked VS monitoring systems.
This paper will also describe the method used to arrive at
alarm threshold and annunciation delays that were accept-
able to the clinical care team.
Once the alarm thresholds and delays were finalized, the
complete system was evaluated throughout an entire care
unit for 5 months to determine the daily per patient total
alarm rate for all VS and the level of acceptance by the non-
ICU nursing staff. The rate of patient deterioration events
was determined during the 5-month pilot of continual, multi-
parameter VS monitoring and compared to that for the same
unit during the previous 5-month period, when we employed
standard manual VS measurements (every 4h pulse check,
respiratory rate, and non-invasive BP monitoring obtained
by a nursing assistant). Pulse oximeters could be ordered
if desired but measurements were not more frequent than
every 2h.
No surveillance monitoring capabilities were available on
our general care units prior to the pilot. Centralized telem-
etry was available for physicians to order on appropriate
patients during the time prior to the pilot as well as during
the pilot. If the patient required cardiac monitoring, both
centralized telemetry and the surveillance monitoring sys-
tem were applied, although the usual proportion of patients
monitored in this fashion was less than 5%.
2 Methods
2.1 Implementation
The site of study was a 26-bed neurologic/neurosurgical
unit with an average of 200 patient-days and 53 patient dis-
charges per week. The nurse-to-patient ratio was 1:5 with a
mostly elderly population undergoing either postoperative
neurosurgical surveillance and standard acute neurologic
care with use of postoperative opioids and other centrally-
acting CNS suppressants. During the 6months antecedent
to study period, vital signs were checked manually and inter-
mittently by nurse aides as ordered by the admitting physi-
cian team. If patients’ vital signs fell into a specific range
determined by the Department of Nursing’s Early Warning
System (EWS), the nurse aide would contact the staff RN
and the rapid response team (RRT) would be called to evalu-
ate and treat the patient. For patients who exhibited risk for
hypoxemia, spot check SpO2 readings using portable pulse
oximeters could be ordered up to every 1h. Since VS data
entry into the EPIC EHR was performed by nursing staff,
Journal of Clinical Monitoring and Computing
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no automated VS entry occurred and the EWS results were
evaluated by the staff nurse with manual implementation of
responses to high EWS scores.
During the period involving evaluation of automated VS
alert systems, we evaluated an FDA-cleared VSAS (ViSi
Mobile System, Sotera Wireless, Inc., San Diego, CA) on
all patients admitted to the same 26-bed Neurosurgery/
Neurology hospital unit (non-ICU) from January 16, 2015
to June 30, 2015. This system continually provided all VS
measurements (BP, HR, RR, SpO2) required for patient care.
The system was connected to the hospital’s existing wireless
network to enable VS information and alarms to be distrib-
uted to a central station and to the nurses’ hospital-supplied
phones (ASCOM, Morrisville, NC). We provided training
to the approximately 23 nurses and 20 nursing assistants
covering all shifts in the study unit. This training included
in-service training on VSAS device use for which the man-
ufacturer provided technical instructors. Clinical safety
personnel in our institution conducted a discussion of the
problem of unrecognized deteriorations, a description of the
alarm threshold policy, and provided two weeks of daily
rounding to identify and correct problems. No additional
staff was added to the existing care team.
The study leadership team (composed of two anesthesi-
ologists and two nurse managers in technical consultation
with representatives of the manufacturer) used an iterative
process to determine alarm threshold limits and annunci-
ation delay (alarm settings) for each VS. Additionally, if
stable patients were found to have VS that were normally
outside of the set parameters, the physician was notified and
the alarm parameters were personalized for that patient to
avoid non-actionable calls to the nursing staff.
For the purposes of evaluating alarm frequency rates dur-
ing the course of the pilot, all VS data were sent to a third-
party cloud database. Our clinicians had access to the cloud
data and used it to determine the alarm rate for the alarm
settings used in the pilot, but also to simulate and provide
interactive feedback on the impact changes in alarm thresh-
old and annunciation delay would have on total alarm rate
[14]. Based on nursing feedback and data analysis every
few days, the clinical manager team then initiated settings
in an effort to reduce the overall alarm burden. Our goal
was to reduce the alarm rate with a soft target of 2alarms/
patient/day (Table1). Although hard evidence does not
exist to establish this as a universal target for hospitalized
patients, our clinical managers in concert with the nursing
staff expressed this target as a manageable but safe goal. This
team evaluated 4 iterations of alarm settings during the first
month of the pilot study before arriving at the final alarm
settings (Table2).
2.2 Data collection
This VSAS device uses proprietary code to sense artefactual
signals and reduce false readings. For example, for SpO2,
if a poor or loss of signal occurred, data was transmitted to
the server as “xx”. The software is setup to then reset the
sequential counting of alarm periods when this occurs. For
example, if an SpO2 of 84% occurred during a 15s epoch
but was followed by an artefact in the next 15s epoch, the
alarm sequence would not restart until another out of range
data point occurred. This was setup to reduce false alarms
with the hope that we would still not miss many true out of
range data points.
Table 1 Overall description and comments regarding alarm parameter changes by time period
APD alarms per patient per day
Date instituted Description Comments APD
1/13/2015 to 1/15/2015 Go live N/A 11.41
1/16/2015 to 2/3/2015 Modify configuration to VSAS defaults Overall reduction of non-actionable alarms 7.09
2/4/2015 to 2/9/2015 Increase high systolic BP alarm limit Reduce non-actionable NIBP alarms—this population kept at
higher systolic
5.94
2/10/2015 to end of study Increase BP and SpO2 alarm delays Further reduction of non-actionable alarms and optimization with
extension distributive alarming
2.01
Table 2 Final vital signs parameters
SpO2 pulse oximeter oxygen saturation, HR heart rate, PR pulse rate,
RR respiratory rate, SBP systolic blood pressure, MAP mean arterial
pressure
Alarm Threshold Delay (s)
SpO2 low 85 90
HR high 150 15
HR low 39 15
PR high 150 60
PR low 39 60
RR high 35 120
RR low 4 120
SBP high 200 240
MAP low 58 60
Journal of Clinical Monitoring and Computing
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The system monitored a total patient of 61,823h with a
maximum session length of 204h and median session length
of 40h. The stored parameter value for each 15-s record was
the median calculated during the 15s of original data.
We also collected patient outcome data: RRT calls, ICU
transfers, and unexpected deaths (not compassionate or hos-
pice care). In addition, we sampled the nursing staff and
patients regarding their impressions about usability of the
VSAS devices and system.
2.3 Data analysis
We analyzed data at daily to weekly intervals during the imple-
mentation of the VSAS on the study nursing unit. The entire
monitoring period ran from January 13, 2015 to June 30, 2015.
The pre-study comparison time period prior to the intervention
of monitoring ran from August 1, 2014 to December 31, 2014.
We compared this site with another other unit that cared for
surgical patients for purposes of trend analysis.
We evaluated our choice of alarm scenario by analyzing the
following variables: frequency of alarm, post-alarm VS at each
15-s interval for 5min, RRT calls, and transfers to the ICU.
All alerts were reviewed, and only alarms meeting the
trigger criteria described earlier were recorded in the data-
base as rescue events. For comparison purposes, we tracked
rescue events per 1000 discharges for patients wearing
VSAS units. We tracked transfers to the ICU as transfers
per 1000 patient-days for all units (as the most commonly
used denominator for patient transfers). We compared all
parametric data outcomes with Students’ t tests, with the
Mann–Whitney test for nonparametric data examining
medians, and with Chi-Square for proportional analysis. We
considered an alpha level of 0.05 as statistically significant.
The statistical software we used was MatLab (MathWorks,
Natick, Massachusetts, USA).
We considered the possibility of hospital care trends that
could affect our dependent variables (e.g., higher awareness
of when to call RRT, etc.) To analyze for temporal patient
monitoring or nursing care trends that could simultane-
ously occur during the study period, we analyzed the same
events in a similar non-ICU medical ward during the same
pre-study and study periods. In that the other unit did not
compare closely to our study unit in terms of patient types,
the acuity levels were similar as measured by the Charlson
Comorbidiy Index (CCI).
3 Results
3.1 Demographics
Patient demographics including age, gender, and acuity level
were similar between the test periods (Table2).
3.2 Vital sign/alarm results
We analyzed a total of 736 patients and accumulated over
30,000h of monitoring, averaging 41h per patient. In terms
of oxygen saturation (SpO2) estimation, the estimated SaO2
from the pulse oximeter produced unusable data in 7.4% of
epochs. Nine hundred and sixty of 1675 (57.3%) of sessions
demonstrated an alarm at some point during the monitor-
ing periods. To a large extent (> 99% of all alarms), alarms
occurred for singular parameters out of range. By default, if
SpO2 data error occurred during measurements (artifact or
poor signal resulting in an inability to calculate the SpO2),
the alarm parameter would restart timing commencing with
the next good signal. Thus, any alarm would be based upon
acceptable signal quality, and would avoid “false” alarms.
The largest number of alarm episodes involved HR, followed
by SpO2.
3.3 Establishing alarm parameters
We set alarm parameters initial to the monitor’s default
mode and adjusted limits for SpO2 and time spent below the
low limit prior to achieving alarm state. Our initial effort
in implementation of the alert system was to limit alarms/
patient/day (APDs) to what our clinical staff regarded as
unobtrusive yet still sensitive enough to avoid false negatives
(significantly altered VS without alarms).
Regarding the monitoring optimization, the process was
that every few days, the clinical managers reviewed alarm
data that resulting from prior thresholds and delays. For each
parameter, the APDs werereviewed, and then the impact of
changes on either threshold or delay were modeled by our
data analysts (with the impact of changes on the prior total
VS dataset). The clinical managers then discussed whether
widening parameters would create a meaningful reduction
of alarm rates and be clinically acceptable considering vari-
ous deterioration scenarios. In other words, would widening
the alarm window still be likely to detect and allow nurses
to intervene on a patient before serious harm would occur.
The managers considered that hypotension, bradycardia,
and hypoxemia would be tolerated for a much shorter time
than tachycardia or hypertension, unless the tachycardia
resulted in hypotension. We usually considered the scenario
in which we required delay before alarm enunciation, and
then a further 90-s delay before escalating via phone alert.
With our historical VS monitoring consisting of every 4h
checks, we regarded that even these apparently wider alarm
limits and delays would still be more likely to pick up dete-
rioration compared to the prior standard.
At the initiation of the study we considered the APDs too
frequent (> 11 APDs) (see Table1.) After day 3, our clini-
cal managers agreed to liberalize the alarm settings. Over
the next 3–4weeks we titrated the alarm limits to gradually
Journal of Clinical Monitoring and Computing
1 3
more acceptable APD results. We considered 2 overall APDs
as desirable. Anecdotally, we simultaneously determined
that false “no alarms” were not occurring on a regular basis.
Our final alarm scenario (see Tables1, 2) resulted in
an overall alarm rate of 2.01alarms/patient/day (APD).
Approximately half of these were from SpO2 alarms (0.97
APD) (Table3). We focused on the oxygen desaturation
results in this project because that was the primary motiva-
tion for our pilot study. Overall, hypoxia (oxygen desatura-
tion: SpO2 < 85%, > 90s) occurred in approximately 0.4% of
15-s epochs recorded, and thus was infrequent in occurrence,
although this resulted in 114h of desaturation in our cadre
of over 700 patients.
Regarding an impression that we were “pushing the limit”
of SpO2 alarms, detailed analysis of post-alarm parameters
indicated that most oxygen saturation levels at 1min after
alarm were higher. Only in 0.6% of SpO2 alarm cases did the
SpO2 not rise above the alarm limit at 1-min post-alarm, and
no cases had a 5-min post-alarm SpO2 less than the alarm
limit of 85%.
Since nursing records were not integrated with the alarm
system, cause and effect cannot be determined. However, we
surmise that this indicates either timely self-rescue or nurs-
ing/healthcare worker rescue. In addition, nursing staff found
the alarm rate to be acceptable in terms of their workload.
3.4 Patient rescue/transfer outcomes
Overall, length of stays (LOSs) were similar between pre-
pilot and intra-pilot study periods (Table4). Rapid Response
Team events during the study time decreased significantly
after implementation of the VSAS (Table5). Transfers to the
ICU also declined, albeit insignificantly, after implementa-
tion of the system. In our comparison unit examining tempo-
ral trends during the same time period, the comparison unit’s
RRT event rates did not significantly change. As in the study
unit, the comparison unit’s ICU transfers also decreased,
although insignificantly.
3.5 Patient deaths
Observed deaths during the VSAS period dropped both in
absolute and relative terms but were not statistically differ-
ent (Table5.) These deaths include those that occurred on
the non-ICU ward and after transfer to ICU. Deaths were
included only if they were not categorized as “Compassion-
ate Care”, otherwise known as In-Hospital Hospice care.
These decreases were not significant statistically in the num-
ber of deaths per 1000 discharges.
4 Discussion
The final stage of implementation of this VSAS continuously
monitored pulse oximetry, HR, RR, NIBP and resulted in a
total alarm rate of 2.3alarms/patient/day which was accepta-
ble to the nursing staff. Patient outcomes during the 5-month
evaluation of the system were compared to outcomes in the
same unit in the 5months preceding the study, where vital
signs were intermittently monitor. The primary finding is
that during the period with continuous monitoring of all vital
signs with the VSAS, we discovered fewer RRT calls and a
decreased need to escalate care to the ICU.
Table 3 Specific SpO2 alarm settings and results by time period
APD alarms per patient per day
Date Low threshold Low delay (s) SpO2 APD
1/13/2015 to 1/15/2015 85 30 1.05
1/16/2015 to 2/3/2015 85 30 2.92
2/4/2015 to 2/9/2015 85 30 2.91
2/10/2015 to end of
study
85 90 0.97
Table 4 Pre- and intra-pilot patient/unit characteristics
M/F male/female, LOS length of stay, W/B/O white, black, other, E/U/R emergency, unscheduled, routine, CCI Charlson Comorbidity Index
(proportions of index = 0,1,2,≥3)
Time period Patient
dis-
charges
Total
patient
days
Gender
(M%/F
%)
Age (year;
median/
SD)
LOS (days;
median/SD)
Race (W/B/O) Admit type (E/U/R) CCI (0,1,2,≥3)
Study unit
5months prior 889 5469 58/42 59.3/15.5 3.0/5.0 81/14/5 60/21/19 0.68/0.12/0.06/0.14
5months intra-pilot 1069 5662 54/46 60.5/14.7 3.0/5.0 80/14/6 63/27/11 0.73/0.09/0.05/0.13
Statistical analysis n/a n/a NS NS NS NS NS NS
Comparison unit
5months prior 1019 6022 57/43 61.3/14.5 6.04/6.87 83/11/6 55/36/9 0.43/0.22/0.08/0.26
5months intra-pilot 979 5108 52/48 60.1/15.5 5.32/5.09 85/10/5 53/37/10 0.42/0.22/0.09/0.22
Statistical analysis n/a n/a NS NS NS NS NS NS
Journal of Clinical Monitoring and Computing
1 3
Deployment of the VSAS was associated with a signifi-
cant drop of RRT calls from 189 to 158 per 1000 patient dis-
charges. In our 26-bed unit, this means an effect size change
from 70 events annualized. ICU transfers declined from 53
to 40 per 1000 discharges, although this was not statistically
significant.
We did detect a diminished death rate during the trial;
however, due to the low number of deaths and minor abso-
lute differences in deaths between the time periods, this did
not achieve statistical significance.
One of our concerns centered on the reduction of alarm
rates while still maintaining safety for our patients. The set-
ting of ≤ 85% SpO2 for > 90s results in an acceptable alarm
rate while maintaining the ability of nurses to rescue patients
who are experiencing episodes of postoperative hypoxemia.
Oxygen saturation levels after alarm onset were higher, indi-
cating either that patients improved on their own or that a
nursing/healthcare worker intervened.
The current standard of care for hospital inpatients is the
sampling of intermittent vital signs and clinical examina-
tions with additional condition monitoring for patients con-
sidered to be at high risk for adverse events. Low nurse-
patient ratios demand a different balance of sensitivity and
specificity when compared with higher staffing ratio sites
such as ORs or ICUs. Continuous patient surveillance can
only be successful if it is not an additional workload to
limited personnel resources while maintaining or improv-
ing efficacy in identifying patient deterioration. Many false
positive alarms (nuisance alarms) will lead staff to become
desensitized, as has been observed in other reports [7, 11].
In contrast, our current work demonstrates that, clinically
actionable alarms gained system acceptance and adoption by
the nursing staff, while providing identification of vital signs
changes that may have led to a decrease in rescue events.
Although the alarm limits are clearly different than those
typically used in the OR, ICU, or condition monitoring situa-
tion—and might appear counterintuitive—they are based on
the fundamentally different approach of triaging and surveil-
lance monitoring in the general care setting.
Staff on the implementation floor were aware of the
ongoing data collection, so that any changes due to the
Hawthorne effect (where performance may improve in
the company of observation) should be similar across
the dataset. The training received by the members of the
VSAS was limited to the use of the new technology and
did not introduce any new general interventional or diag-
nostic techniques. The most common nursing comment is
of a sense of increased knowledge about the status of their
patient-based on the SpO2 and HR information visible on
the in-room monitor (along with remote notification), rein-
forcing the likelihood that any increased nursing attention
is a direct result of the new system, not a by-product of the
guided implementation of the new process.
Monitoring systems other than continuous pulse oxime-
try such as those found in the system we studied, including
CO2 or RR monitoring, are commercially available. Evi-
dence exists that in procedural arenas, capnography, when
used in a 1:1 monitored environment, can help assure air-
way patency [15]. However, several studies with these
devices have found that patient tolerance and compliance
can be too low for them to be used as continuous monitors
in the ward setting and evidence is not strong that they
result in the desired combination of low alarm rates and
reduced care escalation to RRT or ICU status [1618].
Acoustic respiratory monitoring may offer promise but is
limited to a single VS parameter only [15]. Likewise, con-
tinuous pulse oximetry reports indicate conflicting study
results, resulting in questionable value of monitoring with
pulse oximetry as judged by improved reliable outcomes,
effectiveness, and efficiency [19].
Limitations of our study include a lack of granularity
concerning exact causes of the RRT calls and deaths. In
addition, although we include data from a “comparison
unit”, the surgical subspecialties and types of patients
on that unit vary significantly from our study unit. We
hope that aggregate outcomes indicate an improvement
in care, this is largely empirical since we did not conduct
a randomized, controlled trial examining the use of this
monitoring system. We consider the evidence presented
here as preliminary findings only, and understand that the
final judgement on employing these systems remains to
be achieved.
Table 5 RRT events, ICU transfers, unplanned deaths
RRT rapid response team, ICU intensive care unit
Time period Patient discharges RRT events/1000 dis-
charges
ICU transfers/1000 dis-
charges
Unplanned deaths/1000
discharges
Study unit Comp unit Study unit Comp unit Study unit Comp unit Study unit Comp unit
5months prior 889 1053 189 149 52.9 50.3 4.92 1.68
5 months pilot 1069 1000 158 139 40.2 43.0 2.60 1.04
Statistical significance (Z
score for two proportions)
n/a n/a P < 0.05
P = 0.036
NS NS
P = 0.09
NS NS NS
Journal of Clinical Monitoring and Computing
1 3
4.1 Conclusion
In conclusion, our results demonstrate that continuous
patient surveillance can detect alterations in VS, while main-
taining a low rate of alarms, and keep patient outcomes at
least as safe, if not safer, compared to standard intermittent
vital signs monitoring in a neurological/neurosurgical ward
setting. We plan to more fully implement VSAS monitoring
in our acute care settings, leading to larger-scale studies. We
plan further research on patient and event outcomes such
as LOS, urgent rescues by RRT, reductions in escalation
to ICU, and both in-hospital and post-discharge mortality.
Acknowledgements We would also like to thank the hard-working
nurses and other staff on the study unit that endured our staged imple-
mentation, fine-tuning of technical details, and providing feedback
during the study.
Compliance with ethical standards
Conflict of interest The authors have no conflicts of interest to dis-
close, financial or otherwise.
Ethical approval This study was approved by the Wake Forest Univer-
sity Health Sciences Institutional Review Board.
Informed consent Since no PHI information was stored, Informed
consent was waived by the WFUHS IRB.
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... A study at Wake Forest comparing post-implementation data with a pre-implementation historical cohort showed a decrease in rapid response call frequency, which was statistically significant. [24] These results align with the finding of reductions in ICU transfers and rapid response calls reported in a large hospital system in the UK that used the same technology as ours. [25] Using our dataset of 34,636 patients, when contemporaneous propensity-matched intermittent spot checks were compared with continuously monitored postoperative patients, the latter group had a significantly lower likelihood of ICU transfer or death during hospitalisation, along with a reduction in heart failure, myocardial infarction and kidney injury. ...
... Some systematic reviews have concluded that in general there is currently insufficient statistical evidence to support its beneficial effects on clinical outcomes [6,14]. However, it is noteworthy that certain studies have demonstrated a beneficial effect of continuous monitoring on LOS [15][16][17], as well as a reduction in the frequency of RRT calls and ICU admissions [15,[17][18][19][20]. Some even demonstrated a potential reduction in the likelihood of complications and mortality [21,22]. ...
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In Acute Admission Wards, vital signs are commonly measured only intermittently. This may result in failure to detect early signs of patient deterioration and impede timely identification of patient stability, ultimately leading to prolonged stays and avoidable hospital admissions. Therefore, continuous vital sign monitoring may improve hospital efficacy. The objective of this randomized controlled trial was to evaluate the effect of continuous monitoring on the proportion of patients safely discharged home directly from an Acute Admission Ward. Patients were randomized to either the control group, which received usual care, or the sensor group, which additionally received continuous monitoring using a wearable sensor. The continuous measurements could be considered in discharge decision-making by physicians during the daily bedside rounds. Safe discharge was defined as no unplanned readmissions, emergency department revisits or deaths, within 30 days after discharge. Additionally, length of stay, the number of Intensive Care Unit admissions and Rapid Response Team calls were assessed. In total, 400 patients were randomized, of which 394 completed follow-up, with 196 assigned to the sensor group and 198 to the control group. The proportion of patients safely discharged home was 33.2% in the sensor group and 30.8% in the control group (p = 0.62). No significant differences were observed in secondary outcomes. The trial was terminated prematurely due to futility. In conclusion, continuous monitoring did not have an effect on the proportion of patients safely discharged from an Acute Admission Ward. Implementation challenges of continuous monitoring may have contributed to the lack of effect observed. Trial registration: https:// clini caltr ials. gov/ ct2/ show/ NCT05
... Patients felt safe while monitored, which seemed to overcome the physical concerns about the device. Although these findings are in line with multiple references [19,20,22,25,31,32], this is the first study that has performed a formal evaluation 3 years after initial introduction which also identifies four areas to ensure sustainable use. ...
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Background The frequency at which patients should have their vital signs (e.g. blood pressure, pulse, oxygen saturation) measured on hospital wards is currently unknown. Current National Health Service monitoring protocols are based on expert opinion but supported by little empirical evidence. The challenge is finding the balance between insufficient monitoring (risking missing early signs of deterioration and delays in treatment) and over-observation of stable patients (wasting resources needed in other aspects of care). Objective Provide an evidence-based approach to creating monitoring protocols based on a patient’s risk of deterioration and link these to nursing workload and economic impact. Design Our study consisted of two parts: (1) an observational study of nursing staff to ascertain the time to perform vital sign observations; and (2) a retrospective study of historic data on patient admissions exploring the relationships between National Early Warning Score and risk of outcome over time. These were underpinned by opinions and experiences from stakeholders. Setting and participants Observational study: observed nursing staff on 16 randomly selected adult general wards at four acute National Health Service hospitals. Retrospective study: extracted, linked and analysed routinely collected data from two large National Health Service acute trusts; data from over 400,000 patient admissions and 9,000,000 vital sign observations. Results Observational study found a variety of practices, with two hospitals having registered nurses take the majority of vital sign observations and two favouring healthcare assistants or student nurses. However, whoever took the observations spent roughly the same length of time. The average was 5:01 minutes per observation over a ‘round’, including time to locate and prepare the equipment and travel to the patient area. Retrospective study created survival models predicting the risk of outcomes over time since the patient was last observed. For low-risk patients, there was little difference in risk between 4 hours and 24 hours post observation. Conclusions We explored several different scenarios with our stakeholders (clinicians and patients), based on how ‘risk’ could be managed in different ways. Vital sign observations are often done more frequently than necessary from a bald assessment of the patient’s risk, and we show that a maximum threshold of risk could theoretically be achieved with less resource. Existing resources could therefore be redeployed within a changed protocol to achieve better outcomes for some patients without compromising the safety of the rest. Our work supports the approach of the current monitoring protocol, whereby patients’ National Early Warning Score 2 guides observation frequency. Existing practice is to observe higher-risk patients more frequently and our findings have shown that this is objectively justified. It is worth noting that important nurse–patient interactions take place during vital sign monitoring and should not be eliminated under new monitoring processes. Our study contributes to the existing evidence on how vital sign observations should be scheduled. However, ultimately, it is for the relevant professionals to decide how our work should be used. Study registration This study is registered as ISRCTN10863045. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/05/03) and is published in full in Health and Social Care Delivery Research ; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information.
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Background Vital signs measurements on the ward are performed intermittently. This could lead to failure to rapidly detect patients with deteriorating vital signs and worsens long-term outcome. The aim of this study was to test the hypothesis that continuous wireless monitoring of vital signs on the postsurgical ward improves patient outcome. Methods In this prospective, multicenter, stepped-wedge cluster randomized study, patients in the control group received standard monitoring. The intervention group received continuous wireless monitoring of heart rate, respiratory rate and temperature on top of standard care. Automated alerts indicating vital signs deviation from baseline were sent to ward nurses, triggering the calculation of a full early warning score followed. The primary outcome was the occurrence of new disability three months after surgery. Results The study was terminated early (at 57% inclusion) due to COVID-19 restrictions. Therefore, only descriptive statistics are presented. A total of 747 patients were enrolled in this study and eligible for statistical analyses, 517 patients in the control group and 230 patients in the intervention group, the latter only from one hospital. New disability at three months after surgery occurred in 43.7% in the control group and in 39.1% in the intervention group (absolute difference 4.6%). Conclusion This is the largest randomized controlled trial investigating continuous wireless monitoring in postoperative patients. While patients in the intervention group seemed to experience less (new) disability than patients in the control group, results remain inconclusive with regard to postoperative patient outcome due to premature study termination. Clinical trial registration ClinicalTrials.gov, ID: NCT02957825.
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Continual vital sign assessment on the general care, medical-surgical floor is expected to provide early indication of patient deterioration and increase the effectiveness of rapid response teams. However, there is concern that continual, multi-parameter vital sign monitoring will produce alarm fatigue. The objective of this study was the development of a methodology to help care teams optimize alarm settings. An on-body wireless monitoring system was used to continually assess heart rate, respiratory rate, SpO2 and noninvasive blood pressure in the general ward of ten hospitals between April 1, 2014 and January 19, 2015. These data, 94,575 h for 3430 patients are contained in a large database, accessible with cloud computing tools. Simulation scenarios assessed the total alarm rate as a function of threshold and annunciation delay (s). The total alarm rate of ten alarms/patient/day predicted from the cloud-hosted database was the same as the total alarm rate for a 10 day evaluation (1550 h for 36 patients) in an independent hospital. Plots of vital sign distributions in the cloud-hosted database were similar to other large databases published by different authors. The cloud-hosted database can be used to run simulations for various alarm thresholds and annunciation delays to predict the total alarm burden experienced by nursing staff. This methodology might, in the future, be used to help reduce alarm fatigue without sacrificing the ability to continually monitor all vital signs. Electronic supplementary material The online version of this article (doi:10.1007/s10877-015-9790-8) contains supplementary material, which is available to authorized users.
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Purpose: Physiologic monitors are plagued with alarms that create a cacophony of sounds and visual alerts causing "alarm fatigue" which creates an unsafe patient environment because a life-threatening event may be missed in this milieu of sensory overload. Using a state-of-the-art technology acquisition infrastructure, all monitor data including 7 ECG leads, all pressure, SpO(2), and respiration waveforms as well as user settings and alarms were stored on 461 adults treated in intensive care units. Using a well-defined alarm annotation protocol, nurse scientists with 95% inter-rater reliability annotated 12,671 arrhythmia alarms. Results: A total of 2,558,760 unique alarms occurred in the 31-day study period: arrhythmia, 1,154,201; parameter, 612,927; technical, 791,632. There were 381,560 audible alarms for an audible alarm burden of 187/bed/day. 88.8% of the 12,671 annotated arrhythmia alarms were false positives. Conditions causing excessive alarms included inappropriate alarm settings, persistent atrial fibrillation, and non-actionable events such as PVC's and brief spikes in ST segments. Low amplitude QRS complexes in some, but not all available ECG leads caused undercounting and false arrhythmia alarms. Wide QRS complexes due to bundle branch block or ventricular pacemaker rhythm caused false alarms. 93% of the 168 true ventricular tachycardia alarms were not sustained long enough to warrant treatment. Discussion: The excessive number of physiologic monitor alarms is a complex interplay of inappropriate user settings, patient conditions, and algorithm deficiencies. Device solutions should focus on use of all available ECG leads to identify non-artifact leads and leads with adequate QRS amplitude. Devices should provide prompts to aide in more appropriate tailoring of alarm settings to individual patients. Atrial fibrillation alarms should be limited to new onset and termination of the arrhythmia and delays for ST-segment and other parameter alarms should be configurable. Because computer devices are more reliable than humans, an opportunity exists to improve physiologic monitoring and reduce alarm fatigue.
Article
Some preventable deaths in hospitalized patients are due to unrecognized deterioration. There are no publications of studies that have instituted routine patient monitoring postoperatively and analyzed impact on patient outcomes. The authors implemented a patient surveillance system based on pulse oximetry with nursing notification of violation of alarm limits via wireless pager. Data were collected for 11 months before and 10 months after implementation of the system. Concurrently, matching outcome data were collected on two other postoperative units. The primary outcomes were rescue events and transfers to the intensive care unit compared before and after monitoring change. Rescue events decreased from 3.4 (1.89-4.85) to 1.2 (0.53-1.88) per 1,000 patient discharges and intensive care unit transfers from 5.6 (3.7-7.4) to 2.9 (1.4-4.3) per 1,000 patient days, whereas the comparison units had no change. Patient surveillance monitoring results in a reduced need for rescues and intensive care unit transfers.
Article
Alarm fatigue is reported to be a major threat to patient safety, yet little empirical data support its existence in the hospital. To determine if nurses exposed to high rates of nonactionable physiologic monitor alarms respond more slowly to subsequent alarms that could represent life-threatening conditions. Observational study using video. Freestanding children's hospital. Pediatric intensive care unit (PICU) patients requiring inotropic support and/or mechanical ventilation, and medical ward patients. None. Actionable alarms were defined as correctly identifying physiologic status and warranting clinical intervention or consultation. We measured response time to alarms occurring while there were no clinicians in the patient's room. We evaluated the association between the number of nonactionable alarms the patient had in the preceding 120 minutes (categorized as 0-29, 30-79, or 80+ alarms) and response time to subsequent alarms in the same patient using a log-rank test that accounts for within-nurse clustering. We observed 36 nurses for 210 hours with 5070 alarms; 87.1% of PICU and 99.0% of ward clinical alarms were nonactionable. Kaplan-Meier plots showed incremental increases in response time as the number of nonactionable alarms in the preceding 120 minutes increased (log-rank test stratified by nurse P < 0.001 in PICU, P = 0.009 in the ward). Most alarms were nonactionable, and response time increased as nonactionable alarm exposure increased. Alarm fatigue could explain these findings. Future studies should evaluate the simultaneous influence of workload and other factors that can impact response time. Journal of Hospital Medicine 2015. © 2015 Society of Hospital Medicine. © 2015 Society of Hospital Medicine.
Article
The manual collection and charting of traditional vital signs data in inpatient populations have been shown to be inaccurate when compared with true physiologic values. This issue has not been examined with respect to oxygen saturation data despite the increased use of this measurement in systems designed to assess the risk of patient deterioration. Of particular note are the lack of available data examining the accuracy of oxygen saturation charting in a particularly vulnerable group of patients who have prolonged oxygen desaturations (mean SpO2 <90% over at least 15 minutes). In addition, no data are currently available that investigate the often suspected "wake up" effect, resulting from a nurse entering a patient's room to obtain vital signs. In this study, we compared oxygen saturation data recorded manually with data collected by an automated continuous monitoring system in 16 inpatients considered to be at high risk for deterioration (average SpO2 values <90% collected by the automated system in a 15-minute interval before a manual charting event). Data were sampled from the automatic collection system from 2 periods: over a 15-minute period that ended 5 minutes before the time of the manual data collection and charting, and over a 5-minute range before and after the time of the manual data collection and charting. Average saturations from prolonged baseline desaturations (15-minute period) were compared with both the manual and automated data sampled at the time of the nurse's visit to analyze for systematic change and to investigate the presence of an arousal effect. The manually charted data were higher than those recorded by the automated system. Manually recorded data were on average 6.5% (confidence interval, 4.0%-9.0%) higher in oxygen saturation. No significant arousal effect resulting from the nurse's visit to the patient's room was detected. In a cohort of patients with prolonged desaturations, manual recordings of SpO2 did not reflect physiologic patient state when compared with continuous automated sampling. Currently, early warning scores depend on manual vital sign recordings in many settings; the study data suggest that SpO2 ought to be added to the list of vital sign values that have been shown to be recorded inaccurately.
Article
For hospitalized patients with unexpected clinical deterioration delayed or suboptimal intervention is associated with increased morbidity and mortality. Lack of continuous monitoring for average risk patients has been suggested as a contributing factor for unexpected in-hospital mortality. Our objective was to assess the effects of continuous heart rate and respiration rate monitoring in a medical-surgical unit on unplanned transfers and length of stay at the intensive care unit and length of stay at the medical-surgical unit. In a controlled study we have compared a 33-beds medical-surgical unit (intervention unit) to a "sister" control unit for a 9-month pre and a 9-month post implementation period. Following the intervention, all beds in the intervention unit were equipped with monitors that allowed for continuous assessment of heart and respiration rate. We reviewed 7643 patient charts, 2314 that were continuously monitored in the intervention arm and 5329 in the control arms. Comparing the average length of stay of patients hospitalized in the intervention unit following the implementation of the monitors to that prior to the implementation and to that in the control unit we have observed a significant decrease (from 4.0 to 3.6 and 3.6 days respectively; p=<0.01). Total Intensive Care Unit days were significantly lower in the intervention unit post implementation (63.5 versus. 120.1 and 85.36 days/1000 patients respectively; p=0.04). The rate of transfer to the Intensive Care Unit did not change comparing before and after implementation and to the control unit (p=0.19). Rate of code blue events decreased following the intervention from 6.3 to 0.9 and 2.1 respectively per 1000 patients (p=0.02). Continuous monitoring on a medical-surgical unit was associated with a significant decrease in total length of stay in the hospital and in intensive care unit days for transferred patients, as well as lower code blue rates.
Article
Rainbow acoustic monitoring (RRa) utilizes acoustic technology to continuously and noninvasively determine respiratory rate from an adhesive sensor located on the neck. We sought to validate the accuracy of RRa, by comparing it to capnography, impedance pneumography, and to a reference method of counting breaths in postsurgical children. Continuous respiration rate data were recorded from RRa and capnography. In a subset of patients, intermittent respiration rate from thoracic impedance pneumography was also recorded. The reference method, counted respiratory rate by the retrospective analysis of the RRa, and capnographic waveforms while listening to recorded breath sounds were used to compare respiration rate of both capnography and RRa. Bias, precision, and limits of agreement of RRa compared with capnography and RRa and capnography compared with the reference method were calculated. Tolerance and reliability to the acoustic sensor and nasal cannula were also assessed. Thirty-nine of 40 patients (97.5%) demonstrated good tolerance of the acoustic sensor, whereas 25 of 40 patients (62.5%) demonstrated good tolerance of the nasal cannula. Intermittent thoracic impedance produced erroneous respiratory rates (>50 b·min(-1) from the other methods) on 47% of occasions. The bias ± SD and limits of agreement were -0.30 ± 3.5 b·min(-1) and -7.3 to 6.6 b·min(-1) for RRa compared with capnography; -0.1 ± 2.5 b·min(-1) and -5.0 to 5.0 b·min(-1) for RRa compared with the reference method; and 0.2 ± 3.4 b·min(-1) and -6.8 to 6.7 b·min(-1) for capnography compared with the reference method. When compared to nasal capnography, RRa showed good agreement and similar accuracy and precision but was better tolerated in postsurgical pediatric patients.
Article
Alarms are key components of peri-operative monitoring devices, but a high false-alarm rate may lead to desensitisation and neglect. The objective of this study was to quantify the number of alarms and assess the value of these alarms during moderate-risk surgery. For this purpose, we analysed documentation of anaesthesia workstations during 38 surgical procedures. Alarms were classified on technical validity and clinical relevance. The median (IQR [range]) alarm density per procedure was 20.8 (14.5-34.2 [3.7-85.6]) alarms.h(-1) (1 alarm every 2.9 min) and increased during induction and emergence of anaesthesia, with up to one alarm per 0.99 min during these periods (p < 0.001). Sixty-four per cent of all alarms were clinically irrelevant, whereas 5% of all alarms required immediate intervention. The positive predictive value of an alarm during induction and emergence was 20% (95% CI 16-24%) and 11% (95% CI 8-14%), respectively. This study shows that peri-operative alarms are frequently irrelevant, with a low predictive value for an emerging event requiring clinical intervention.
Article
ISTORICALLY, anesthesiologists seem to be the forerunners in implementing tools and standards for safety in the medical fraternity. In the United States, since 1985, there has been a dramatic decrease in the malpractice insurance premiums of anesthesiologists. Such a decrease has not been seen in other medical or surgical specialties over this time frame. Thanks to the foresight of the American Society of Anesthesiologists (ASA), Anesthesia Patient Safety Foundation (APSF), Association of Anaesthetists of Great Britain and Ireland (AAGBI), and the Association of Anesthesiologists in Holland, capnography was embraced and incorporated into the standards of monitoring during anesthesia to enhance patient safety. Currently, anesthesiologists in many developing countries follow these recommendations (India, Government of Andhra Pradesh Order, AST/775/F25/dated September 2011. Capnography is mandatory for laparo