Figure
Source publication
Rationale: Pediatric-specific ventilator liberation guidelines are lacking despite the many studies exploring elements of extubation readiness testing. The lack of clinical practice guidelines has led to significant and unnecessary variation in methods used to assess pediatric patients' readiness for extubation. Methods: Twenty-six international ex...
Contexts in source publication
Context 1
... suggest using either pressure support (PS) augmentation with continuous positive airway pressure (CPAP) or CPAP alone during SBTs in mechanically ventilated children at standard risk for extubation failure (Table 4). (Conditional recommendation, very low certainty of evidence) For children at higher risk of extubation failure (Table 4), we suggest using CPAP without PS augmentation during SBTs for better assessment of extubation readiness. ...Context 2
... suggest using either pressure support (PS) augmentation with continuous positive airway pressure (CPAP) or CPAP alone during SBTs in mechanically ventilated children at standard risk for extubation failure (Table 4). (Conditional recommendation, very low certainty of evidence) For children at higher risk of extubation failure (Table 4), we suggest using CPAP without PS augmentation during SBTs for better assessment of extubation readiness. (Conditional recommendation, very low certainty of evidence) Table 2. Guidelines PICO Questions and Summary of Recommendations ...Context 3
... recommendation, very low certainty of evidence) REMARKS. For children at high risk of extubation failure (Table 4), the panel considered a longer SBT of 60-120 minutes as more appropriate. RATIONALE. ...Context 4
... high-risk patients, SBT durations between 60 and 120 minutes were considered the most appropriate, given that preventing extubation failure is a higher priority, and a 60-120-minute SBT was considered to have higher diagnostic accuracy. Risk factors considered for highrisk patients are summarized in Table 4. Recommendation 7. We suggest using measurement of maximal inspiratory pressure during airway occlusion (PiMax) as an element of the ERT bundle for critically ill children at risk for muscle weakness or at risk for extubation failure. ...Context 5
... children at high risk for extubation failure, we suggest using noninvasive respiratory support (NRS; including HFNC, CPAP, or NIV) over conventional oxygen therapy immediately after extubation (Table 4) For children .1 year of age who are started on NRS; CPAP, HFNC, and NIV are appropriate first-line therapies, and the choice will depend on the clinical setting and patient circumstances. NIV can be considered if CPAP or HFNC does not relieve postextubation respiratory distress or for children who receive NIV for other chronic conditions. ...Similar publications
Introduction The criteria for the removal of the tracheostomy tube (decannulation) vary from center to center. Some perform an endoscopic evaluation under anesthesia or computed tomography, which adds to the cost and discomfort. We use a simple two-part protocol to determine the eligibility and carry out the decannulation: part I consists of airway...
Citations
... The latest PALISI network guidelines recommend performing the CLT before extubation in children, despite underlying evidence of only very low certainty. 13 The qualitative variants of the CLT consists in listening for expired air around the endotracheal tube when the cuff is deflated. Sensitivity for predicting PERD is low, probably due to the subjective nature of the assessment. ...
... The paucity of available evidence has not allowed the development of strong recommendations about Open access performing a qtCLT before the extubation of paediatric patients. 13 To our knowledge, this is the first multicentre study evaluating the performance of the qtCLT in predicting the risk of UAO-PERD after extubation in the PICU. The age range is broad, from 2 days up to including 17 years. ...
Introduction
In children, respiratory distress due to upper airway obstruction (UAO) is a common complication of extubation. The quantitative cuff-leak test (qtCLT) is a simple, rapid and non-invasive test that has not been extensively studied in children. The objective of the ongoing study whose protocol is reported here is to investigate how well the qtCLT predicts UAO-related postextubation respiratory distress in paediatric intensive care unit (PICU) patients.
Methods and analysis
Air Leak Test in the Paediatric Intensive Care Unit is a multicentre, prospective, observational study that will recruit 900 patients who are aged 2 days post-term to 17 years and ventilated through a cuffed endotracheal tube for at least 24 hours in any of 19 French PICUs. Within an hour of planned extubation, the qtCLT will be performed as a sequence of six measurements of the tidal volume with the cuff inflated then deflated. The primary outcome is the occurrence within 48 hours after extubation of severe UAO defined as combining a requirement for intravenous corticosteroid therapy and/or ventilator support by high-flow nasal cannula and/or by non-invasive ventilation or repeat invasive mechanical ventilation with a Westley score ≥4 with at least one point for stridor at each initiation. The results of the study are expected to identify risk factors for UAO-related postextubation respiratory distress and extubation failure, thereby identifying patient subgroups most likely to require preventive interventions. It will also determine whether qtCLT appears to be a reliable method to predict an increased risk for postextubation adverse events as severe UAO.
Ethics and dissemination
The study was approved by the Robert Debré University Hospital institutional review board (IRB) on September 2021 (approval #2021578). The report of Robert Debré University Hospital IRB is valid for all sites, given the nature of the study with respect to the French law. The results will be submitted for publication in a peer-reviewed journal.
Trial registration number
NCT05328206 .
... These changes can aggravate cerebral ischemia or swelling and pulmonary arterial hypertension. Prolonged intubation and delayed weaning increase the risk of chronic lung disease, prolonged PICU stay, critical illness neuromyopathy, and worse patient-centred outcomes 8 . ...
Introduction
Digital trials are a promising strategy to increase the evidence base for common interventions and may convey considerable efficiency benefits in trial conduct. Although paediatric intensive care units (PICUs) are rich in routine electronic data, highly pragmatic digital trials in this field remain scarce. There are unmet evidence needs for optimal mechanical ventilation modes in paediatric intensive care. We aim to test the feasibility of a digital PICU trial comparing two modes of invasive mechanical ventilation using carbon dioxide (CO 2 ) control as the outcome measure.
Methods and analysis
Single-centre, open-labelled, randomized controlled pilot trial with two parallel treatment arms comparing pressure control (PC) vs pressure-regulated volume control (PRVC). Patients are eligible if aged <18 years, weighing >2 kg, have an arterial line, and require >60 minutes of mechanical ventilation during PICU hospitalization at the University Children’s Hospital Zurich. Exclusion criteria include cardiac shunt lesions, pulmonary hypertension under treatment, and intracranial hypertension. CO 2 is measured using three methods: end-tidal (continuous), transcutaneous (continuous), and blood gas analyses (intermittent). Baseline, intervention, and outcome data are collected electronically from the patients’ routine electronic health records. The primary feasibility outcome is adherence to the assigned ventilation mode, while the primary physiological outcome is the proportion of time spent within the target range of CO 2 (end-tidal, normocarbia defined as CO 2 ≥ 4.5, ≤ 6 kPa). Both outcomes are captured digitally every minute from randomization until censoring (48 hours after randomization, extubation, discharge, or death, whichever comes first). Analysis will occur on an intention-to-treat basis. We aim to enrol 60 patients in total. Recruitment started in January 2024 and is planned to continue for 6 months.
Ethics and dissemination
This study received ethical approval (BASEC 2022-00829). Study results will be disseminated through publication in a peer-reviewed journal and other media like podcasts.
Trial registration number
NCT058431
ARTICLE SUMMARY
This study compares two commonly used modes of invasive mechanical ventilation in a randomized design. The trial will provide feasibility data to inform the conduct of digital trials by using electronic patient data directly extracted from the source systems, minimizing manual data collection and associated bias and thereby increasing local readiness for more efficient clinical trial conduct.
Outcomes of this pilot trial relate to feasibility and physiological measures; future larger trials should also explore patient-centred outcomes.
Blinding is not possible due to the nature of the intervention.
Technical issues that may affect the availability or accuracy of data may arise and will be documented.
Some aspects of digital trials, such as electronic informed consent, are not implemented in this trial.
... In total, 27 additional cases were studied for various combinations of V T , breathing frequency, inspiratory to expiratory ratio (I:E), and _ V NC in the selected High-Flow Oxygen Delivery. High-flow oxygen delivery, as defined in the context of this study, refers to the administration of oxygen at flows > 2 L/min for infants [50][51][52][53] and > 15 L/min for adults. 54,55 New experiments were conducted in the present study for both infant and adult airway replicas to evaluate F DO 2 delivered during high-flow oxygen therapy. ...
Background:
The nasal cannula is widely regarded as a safe and effective means of administering low- and high-flow oxygen to patients irrespective of their age. However, variability in delivered oxygen concentration (FDO2 FDO2 ) via nasal cannula has the potential to pose health risks. The present study aimed to evaluate predictive equations for FDO2 over a large parameter space, including variation in breathing, oxygen flow, and upper-airway geometry representative of both young children and adults.
Methods:
Realistic nasal airway geometries were previously collected from medical scans of adults, infants, and neonates. Nasal airway replicas based on these geometries were used to measure the FDO2 for low-flow oxygen delivery during simulated spontaneous breathing. The present study extends previously published data sets to include higher oxygen flows. The extended data sets included nasal cannula oxygen flows that ranged from 6 to 65 L/min for the adult replicas, and from 0.5 to 6 L/min for the infant replicas. For both age groups, FDO2 was measured over a range of breathing frequencies, inspiratory to expiratory time ratios, and tidal volumes. Measured FDO2 values were compared with values predicted by using a previously derived flow-weighted equation.
Results:
For both age groups, FDO2 was observed to increase nonlinearly with the ratio between oxygen flow supplied to the nasal cannula and the average inhalation flow. The previously derived flow-weighted equation over-predicted FDO2 at higher oxygen flows. A new empirical equation, therefore, was proposed to predict FDO2 for either age group as a function of nasal cannula flow, tidal volume, and inspiratory time. Predicted FDO2 values matched measured values, with average relative errors of 2.4% for infants and 4.3% for adults.
Conclusions:
A new predictive equation for FDO2 was obtained that accurately matched measured data in both adult and infant airway replicas for low- and high-flow regimens.
... 본 종설에서는 입문자를 위한 소아 침습적 기계환 기의 실제 초기 적용에 대해 다루고자 한다. 기계환기 원리, 모드 (mode), 모니터링(monitoring) 및 이탈(weaning)을 포함한 전반적인 내용에 대해서는 다른 문헌을 참고하기 바란다 [2][3][4]. ...
... 4 Prompt identification of patients ready to be extubated is desirable to reduce morbidity associated with prolonged mechanical ventilation, such as diaphragmatic dysfunction, delirium, ventilator-associated pneumonia, and ICU-acquired weakness. 5,6 To minimize the time on mechanical ventilation, daily assessment of extubation readiness testing (ERT) eligibility is strongly recommended for children receiving invasive mechanical ventilation. 5 Eligibility for ERT is predicated on several conditions being met, including hemodynamic stability, resolution of the underlying reason for mechanical ventilation, appropriate neurologic status, effective cough and gag, chest radiograph without limiting findings, ability to breathe spontaneously, adequate analgosedation, and mechanical ventilator settings at or below acceptable thresholds. ...
... 5,6 To minimize the time on mechanical ventilation, daily assessment of extubation readiness testing (ERT) eligibility is strongly recommended for children receiving invasive mechanical ventilation. 5 Eligibility for ERT is predicated on several conditions being met, including hemodynamic stability, resolution of the underlying reason for mechanical ventilation, appropriate neurologic status, effective cough and gag, chest radiograph without limiting findings, ability to breathe spontaneously, adequate analgosedation, and mechanical ventilator settings at or below acceptable thresholds. ERT protocols typically use thresholds for peak inspiratory pressure (PIP), PEEP, and F IO 2 , 6,7 although some protocols may include other mechanical ventilation parameters such as mean airway pressure (P aw ) 8 or D pressure. ...
... 2 Mechanical ventilator setting thresholds for ERT eligibility vary in published studies 1,8,9 and the recent ventilator liberation guidelines did not make specific recommendations with regard to ventilator settings for ERT eligibility. 5 In addition, published studies have largely excluded children with congenital heart disease. The single clinical trial done in children with congenital heart disease used ventilator setting thresholds of PIP # 20 cm H 2 O, PEEP of 5 cm H 2 O, and F IO 2 # 0.50. 1 Despite the strong recommendations for standardized daily ERT screening, the precise mechanical ventilator parameters for extubation ERT in children with congenital heart disease remain unknown. ...
Background:
In children with congenital heart disease, extubation readiness testing (ERT) is performed to evaluate the potential for liberation from mechanical ventilation. There is a paucity of data that suggests what mechanical ventilation parameters are associated with successful ERT. We hypothesized that ERT success would be associated with certain mechanical ventilator parameters.
Methods:
Data on daily ERT assessments were recorded as part of a quality improvement project. In accordance with our respiratory therapist-driven ventilator protocol, patients were assessed daily for ERT eligibility and tested daily, if eligible. Mechanical ventilation parameters were categorized a priori to evaluate the differences in levels of respiratory support. The primary outcome was ERT success.
Results:
A total of 780 ERTs from 320 subjects (median [interquartile range] age 2.5 [0.6-6.5] months and median weight [interquartile range] 4.2 [3.3-6.9] kg) were evaluated. A total of 528 ERTs (68%) were passed, 306 successful ERTs (58%) resulted in extubation, and 30 subjects (9.4%) were re-intubated. There were statistically significant differences in the ERT pass rate for ventilator mode, peak inspiratory pressure, Δ pressure, PEEP, mean airway pressure (P̅aw), and dead-space-to-tidal-volume ratio (all P < .001) but not for FIO2 . ERT success decreased with increases in peak inspiratory pressure, Δ pressure, PEEP, P̅aw, and dead-space-to-tidal-volume ratio. Logistic regression revealed neonates, Δ pressure ≥ 11 cm H2O, and P̅aw > 10 cm H2O were associated with a decreased odds of ERT success, whereas children ages 1-5 years and an FIO2 of 0.31-0.40 had increased odds of ERT success.
Conclusions:
ERT pass rates decreased as ventilator support increased; however, some subjects were able to pass ERT despite high ventilator support. We found that P̅aw was associated with ERT success and that protocols should consider using P̅aw instead of PEEP thresholds for ERT eligibility. Cyanotic lesions were not associated with ERT success, which suggests that patients with cyanotic heart disease can be included in ERT protocols.
... Recent published guidelines on pediatric ventilator liberation recommend the use of noninvasive respiratory support in patients at high risk of extubation failure based on very low certainty of evidence. 25 Examples of patients considered "high-risk" included patients with chronic lung disease, myocardial dysfunction, neuromuscular impairment, and prolonged mechanical ventilation (> 14 d) but not pediatric ARDS per se. The use of CPAP and HFNC as noninvasive respiratory support was also shown to be more effective than conventional low-flow oxygen therapy in preventing extubation failure. ...
... However, in the systematic reviews and current recommendations of evidence-based clinical practice guidelines for the pediatric population on weaning from MV and extubation, there are no sections that Invasive Mechanical Ventilation -M. Ibarra V. et al particularly address the issue of nocturnal extubation in the pediatric ICU in the different health realities and at different levels of complexity 14,15 . ...
There is little known about the time of the day and the nature of it (business day/non-business day) at which extubation is performed, and whether it is safe during the night. Objective: to describe the frequency of nocturnal extubation (NE) and non-business day extubation (nBDE). In addition, to determine the association between these and clinical outcomes. Patients and Method: Retrospective cohort study of patients under 18 years of age who received invasive mechanical ventilation (MV) and underwent an extubation attempt in a high complexity Pediatric Critical Patient Unit (PCPU) between 01/01/2018 to 12/31/2021. Primary exposure: NE, which was defined as that performed between 20:01 and 8:00 hours. Its association with extubation failure (EF), duration of invasive MV, and length of stay in the PCPU was evaluated. Results: 146 patients were included [58.9% males, age 1.14 (0.25 - 5.5) years]. NE was performed in 17.8%. Nocturnal extubation was not associated with EF nor was the day of extubation. The EF was 3.8% in NE and 5% in daytime extubation (DE) (p=0.80). Duration of invasive MV was shorter in NE than DE [48 (24-73.5) vs 72 (48-96) h, p=0.02]. Conclusions: NE was not associated with EF. Patients with NE had shorter duration of invasive MV, and the latter was associated with EF. Withdrawal of invasive MV should be considered at the first opportunity and be determined by clinical factors, rather than time of day.
... El equipo multidisciplinario a cargo del paciente pediátrico grave debe siempre propender el equilibrio entre la disminución de la duración de la VM invasiva, el riesgo de FE y el desarrollo de comorbilidades asociadas 13 . No obstante, en las revisiones sistemáticas y recomendaciones vigentes de directrices de prácticas clínicas basadas en la evidencia para la población infantil, sobre destete de la VM y extubación, no existen apartados que aborden particularmente el tema de la extubación nocturna en UCI pediátrica en las diversas realidades sanitarias y de distintos niveles de complejidad existentes 14,15 . En nuestro cohorte, la tasa de FE observada (4,7%) está en el rango inferior de lo habitualmente reportado 16 , y específicamente dentro del rango comunicado (3%-8%) en latinoamérica 17,18 . ...
Unlabelled:
There is little known about the time of the day and the nature of it (business day/non-business day) at which extubation is performed, and whether it is safe during the night.
Objective:
to describe the frequency of nocturnal extubation (NE) and non-business day extubation (nBDE). In addition, to determine the association between these and clinical outcomes.
Patients and method:
Retrospective cohort study of patients under 18 years of age who received invasive mechanical ventilation (MV) and underwent an extubation attempt in a high complexity Pediatric Critical Patient Unit (PCPU) between 01/01/2018 to 12/31/2021. Primary exposure: NE, which was defined as that performed between 20:01 and 8:00 hours. Its association with extubation failure (EF), duration of invasive MV, and length of stay in the PCPU was evaluated.
Results:
146 patients were included [58.9% males, age 1.14 (0.25 - 5.5) years]. NE was performed in 17.8%. Nocturnal extubation was not associated with EF nor was the day of extubation. The EF was 3.8% in NE and 5% in daytime extubation (DE) (p = 0.80). Duration of invasive MV was shorter in NE than DE [48 (24-73.5) vs. 72 (48-96) h, p = 0.02].
Conclusions:
NE was not associated with EF. Patients with NE had shorter duration of invasive MV, and the latter was associated with EF. Withdrawal of invasive MV should be considered at the first opportunity and be determined by clinical factors, rather than time of day.
... 6 Subgroup analysis revealed that children < 12 months of age seemed to benefit the most from CPAP. 6 Based largely on that trial, 6 current ventilator liberation guidelines recommend the use of CPAP over HFNC in children < 12 months of age requiring respiratory support at extubation (conditional recommendation). 7 There are limited data on the use of rescue NIV for postextubation respiratory failure in children, 8 and rescue NIV is not currently recommended in adults. 9 In addition to a dearth of supportive data, other challenges for the utilization of NIV in small children include its poor tolerance, lack of pediatricapproved devices, and paucity of interfaces specifically designed for children. ...
Background:
Infants with a high risk of extubation failure are often treated with noninvasive ventilation (NIV) or CPAP, but data on the role of these support modalities following extubation are sparse. This report describes our experience using NIV or CPAP to support infants following extubation in our pediatric ICUs (PICUs).
Methods:
We performed a retrospective study of children < 10 kg receiving postextubation NIV or CPAP in our PICUs. Data on demographics, medical history, type of support, vital signs, pulse oximetry, near-infrared spectroscopy (NIRS), gas exchange, support settings, and re-intubation were extracted from the electronic medical record. Support was classified as prophylactic if planned before extubation and rescue if initiated within 24 h of extubation. We compared successfully extubated and re-intubated subjects using chi-square test for categorical variables and Mann-Whitney test for continuous variables.
Results:
We studied 51 subjects, median age 44 (interquartile range 0.5-242) d and weight 3.7 (3-4.9) kg. There were no demographic differences between groups, except those re-intubated were more likely to have had cardiac surgery prior to admission (0% vs 14%, P = .040). NIV was used in 31 (61%) and CPAP in 20 (39%) subjects. Prophylactic support was initiated in 25 subjects (49%), whereas rescue support was needed in 26 subjects (51%). Twenty-two subjects (43%) required re-intubation. Re-intubation rate was higher for rescue support (58% vs 28%, P = .032). Subjects with a pH < 7.35 (4.3% vs 42.0%, P = .003) and lower somatic NIRS (39 [24-56] vs 62 [46-72], P = .02) were more likely to be re-intubated. The inspiratory positive airway pressure, expiratory positive airway pressure, and FIO2 were higher in subjects who required re-intubation.
Conclusions:
NIV or CPAP use was associated with a re-intubation rate of 43% in a heterogeneous sample of high-risk infants. Acidosis, cardiac surgery, higher FIO2 , lower somatic NIRS, higher support settings, and application of rescue support were associated with the need for re-intubation.
... 1,2 Successful extubation is a key endpoint of weaning, hence assessment for extubation readiness has received a lot of attention recently. 3,4 Although the terms Spontaneous Breathing Trial (SBT) and Extubation Readiness Test (ERT) are used interchangeably in literature, SBT determines the ability to sustain spontaneous breathing with minimal support whereas ERT encompasses SBT as well as assessment of other elements (levels of sedation, neurological status, and risk of upper airway obstruction) required for successful extubation. 2,4 Studies in mechanically ventilated adults have shown varied success rates of SBTs in reducing length of invasive ventilation, its complications, and healthcare costs. ...
... 20,21 The recent international guidelines for pediatric ventilator liberation suggested using either PS or CPAP during SBT but it was only a conditional recommendation due to very low certainty of evidence. 3 To address this data gap, we ...
... 12 Khemani Articles it only by 17-25%, thus flagging the concern for the use of PS in SBT. 14 children. 2 The recent clinical practice guidelines however failed to arrive at a consensus for the preferred method of SBT due to lack of robust evidence. 3 The only previous randomized controlled trial in children by Farias et al. comparing 2-h SBT using PS of 10 cm H 2 O versus T-piece showed no significant difference in extubation failure between the two methods. 20 Our results complement the findings of this trial in that the extubation failure rates are not higher with PS SBT in clinical settings. ...
Background:
Pressure support (PS) as a spontaneous breathing trial (SBT) was considered inferior to continuous positive airway pressure (CPAP) and T-piece because PS underestimated post-extubation work of breathing in physiologic studies. We aimed to compare PS and CPAP as SBT methods for assessing clinical outcomes in children.
Methods:
This was an open label randomized non-inferiority trial conducted between December 2019 and August 2021 among children aged 1 month to 12 years deemed ready for weaning after at least 48 h of invasive ventilation in PICU. Children were randomized to undergo a 2-h SBT with PS of 8 cm H2O in addition to PEEP 5-6 cm H2O or CPAP (5-6 cm H2O). The primary outcome was successful liberation from invasive ventilation for 72 h after first SBT. Secondary outcomes included first SBT pass rate, need for post-extubation respiratory support (high flow oxygen and/or non-invasive ventilation), and length of PICU stay.
Findings:
Of the 247 enrolled children, 244 completed the trial (121 in PS and 123 in CPAP group). Median (IQR) age was 24 (9, 84) months. Median (IQR) duration of invasive ventilation before randomization was 4.5 (3, 6.5) days. Successful liberation from invasive ventilation after first SBT occurred in 97 (80.2%) children in PS and 93 (75.6%) children in CPAP group [difference 4.6; 95% CI (-5.8, 15); p = 0.39]. First SBT pass rate between PS and CPAP [111 (91.7%) versus 105 (85.4%); difference 6.3; 95% CI (-1.6, 14.3); p = 0.12] was similar. Need for post-extubation respiratory support [52 (43%) versus 49 (40%)], rate of reintubation within 72 h [14 (11.6%) versus 12 (9.8%)] and median (IQR) length of PICU stay [9 (6, 15) versus 8 (5.5, 13) days] were comparable. Four (1.6%) children, all in CPAP group had unfavourable outcome (1 died, 3 discontinued care).
Interpretation:
In invasively ventilated children, 2-h SBT with pressure support was non-inferior to CPAP in predicting successful liberation from invasive ventilation.
Funding:
None.
