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The Feasibility of postpyloric feeding tube placement in thrombocytopenic +/- anticoagulated
patients on the intensive care unit
CORTRAK in thrombocytopenic patients
Stephanie-Susanne Stecher, MD1; Michaela Barnikel, MD³; Heidrun Drolle, MD²; Alexandra
Pawlikowski, MD²; Johanna Tischer, MD2; Tobias Weiglein, MD2; Annabel Alig, MD2; Sofia Anton,
MD1; Hans Joachim Stemmler, MD2*; and Alessia Fraccaroli, MD2
1 Department of Medicine II, 2 Department of Medicine III, ³ Department of Medicine V
University Hospital, LMU, Munich, Germany
*Corresponding author
Abstract word count 377
Manuscript word count 2.641
Number of references 24
Number of figures and tables 2 tables, 4 figures
Number of supplemental illustrations/tables -
This article is protected by copyright. All rights reserved.
Corresponding author
Prof. Dr. med. Hans Joachim Stemmler
Intensive Care Unit - Medical Department II, III & V
University Hospital LMU Munich
Marchioninistr. 15
81377 München
Germany
Telephone: +49 89 4400 75835
Fax: +49 89 4400 72221
Email: Joachim.Stemmler@med.uni-muenchen.de
Abstract
Purpose
Enteral nutrition (EN) is considered as a cornerstone in the management of critically ill patients.
However, its successful initiation is frequently hampered by various complications occurring in
patients treated in the ICU. Successful placement of a nasojejunal tube by Cortrak enteral access
system (CEAS) has been reported to be a simple bedside tool for placing the postpyloric (PP) feeding
tube.
Patients and Methods
We evaluated the efficacy and side effects using CEAS to establish EN in critical ill, thrombocytopenic
and/or anticoagulated patients.
Results
Fifty-six mechanically ventilated patients were analysed, 24 of them underwent prior
haematopoietic stem cell transplantation (SCT). Sixteen patients received ECMO treatment due
ARDS. The median platelet count at PP placement was 26 G/l (range: 4 – 106 G/l); 16 patients
received therapeutic anticoagulation (aPTT 50-70 s.). CEAS assisted placement of a PP nasojejunal
tube was performed successfully in all patients . The most frequent adverse event was epistaxis in 27
patients (48.2 %) which was mostly mild (CTCAE grade 1, n = 21 (77.8 %); grade 2, n = 6). A significant
association between a low platelet count and bleeding complications was observed (p <0.001).
Conclusions
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Performed by an experienced operator, CEAS is a simple, rapid available and effective bedside tool
for safely placing PP feeding tubes for enteral nutrition in thrombocytopenic patients, even when
showing an otherwise caused coagulopathy in the ICU. Higher grade bleeding complications were
not observed despite their obvious correlation to thrombocytopenia. A prospective study is in
preparation.
Keywords
Feeding tube, enteral nutrition, CEAS, thrombocytopenia, anticoagulation, cancer patients
Introduction
The ESICM Working Group on Gastrointestinal Function provided clinical practice guidelines on early
enteral nutrition (EEN) and suggested to initiate it as soon as possible at a low rate, as beneficial
effects regarding infection prevention have been demonstrated in critically ill patients (1).
Postponed enteral nutrition was only suggested in patients with uncontrolled shock, uncontrolled
hypoxemia and acidosis, uncontrolled GI bleeding, gastric aspirate volume > 500 ml/6 h and various
intra-abdominal problems (2). Enteral nutrition is also recommended as first-line nutritional support
for patients suffering from haematological disorders, especially after allogeneic haematopoietic
stem cell transplantation (3). However, its promptly onset is often hampered by severe
thrombocytopenia and/or high-grade mucositis implicating potentially severe complications.
Considering the emerging evidence regarding the association between gut microbiota dysbiosis and
acute graft-versus-host disease (GVHD) occurrence, a protective effect of nutrition was also
attributed to the improved gut eubiosis observed in enterally fed patients (3). Therefore, EEN should
be initiated soon in those patients, latest at ICU admission.
Initiating EN via a gastric tube is technically easier and may decrease the time to initiation of EN.
Gastric access should therefore be used as the standard appraoach to initiate EN (4, 5). Although PP
alimentation may be associated with a reduction in pneumonia in critically ill patients, there is no
difference in mortality between PP and gastric EN (4, 5). Current guidelines recommend PP feeding
in patients with an increased risk for aspiration.. But yet, positioning of enteral feeding tubes
necessitates endoscopy for reliable PP placement. Endoscopic insertion is so far considered the gold
standard for insertion of PP feeding tubes with high success rate, however it involves manpower
carries implications on patient safety issues (7). The latter may be of importance, particularly in
haemato-/oncological patients comprised by thrombocytopenia and/or on anticoagulants, suffering
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from mucositis in addition to the presence of life-threatening complications such as septic shock
including disseminated intravascular coagulation (DIC), severe pneumonia and other organ failures
which warranted admission to the ICU.
Cortrak Enteral Access System (CEAS; CORPAK MedSystems, IL, USA) is an electromagnetic sensing
device that tracks and displays the path of feeding tubes during the placement procedure. Due to
real time tracking of the tube tip position, this approach may improve successful tube placement
quota, reduce overall placement-time and might even diminish the need for confirmatory X-rays
after intervention. Beside a thrombopenic and/or anticoagulated patient cohort, CEAS has proven
efficacy and safety in numerous studies when performed by an experienced operator, minimizing
operator pitfalls and patient risks (7-15). Yet, there is just few data available on feasibility and
complications in critically ill patients, in particular when focusing on patients with coagulopathies
caused by e.g. chemotherapy-induced thrombocytopenia, application of heparin, DIC, hepatic failure
or other causes (16, 17).
This retrospective analysis was conducted to evaluate the feasibility, safety and effectiveness of the
CEAS in establishing nasojejunal nutrition after admission to the ICU in a thrombocytopenic and/or
otherwise anticoagulated patient cohort suffering predominantly from haemato-oncological disease.
Materials and methods
We retrospectively analysed the use of CEAS for insertion of a feeding tube in a thrombocytopenic
and/or anticoagulated patient cohort between 2017 and 2019 at the Haematology/Oncology and
Gastroenterology ICU of the University Hospital of the Ludwig-Maximilians University of Munich,
Campus Grosshadern. Necessity for PP feeding resulted from insufficient nutrition via a gastric tube
due to high reflux.
The study was conducted in accordance with the Declaration of Helsinki. The ethics committee of
the Ludwig-Maximilians University of Munich recognized the retrospective evaluation and waived
the need for informed consent because of the non-interventional design of the investigation.
We evaluated the success rate, number of attempts, time requirement and the adverse events of
using the CEAS for PP feeding tube placement. Age, gender, characteristics of
haematological/oncological disease, platelet count at placement, platelet transfusion, therapeutic
anticoagulation(aPTT 50 – 70 sec.), as well as treatment and the reason for ICU admission were
recorded.
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Nasojejunal feeding tube was placed using the Cortrak Enteral Access System (CEAS; CORPAK
MedSystems, IL, USA). The tube was watered for a few minutes for better lubrification and
placement time was recorded starting with the beginning of the tube insertion. Time for preparation
procedures was not included. The PP position of the tube tip was confirmed by abdominal X-ray,
using 10 ml of water-soluble contrast agent given immediately prior to X-ray via tube
(GASTROGRAFIN 76% 100ml N1, Lösg., Bayer Vital). When the trace shown by the electromagnetic
sensing device showed typical and highly suggestive placement in the small bowel at the end of the
placement procedure, confirmation by X-ray was omitted (fig. 1, 2).
All nasojejunal tube placements were performed by the same experienced operator (> 500
successful placements). In patients, suffering from chemotherapy induced severe mucositis, higher-
grade mucosal acute GvHD, severe thrombocytopenie and pre-existing epistaxis events prior to the
procedure, platelet concentrates were transfused in pre-emptive intention prior to placement.
Definitions (grading of pre-existing conditions and adverse events)
Due to the fact that the majority of the patients suffered from haemato-oncological disease, grading
of pre-existing conditions as epistaxis, mucositis and low platelet number was graded according to
the NCI Common Terminology Criteria for Adverse Events. It is a descriptive terminology which can
be utilized for Adverse Event (AE) reporting
(https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Refe
rence_5x7.pdf)
platelet count
The majority of the haematological patients suffered from treatment-induced thrombocytopenia.
The platelet count at the time of CEAS insertion was graded according to the CTCAE v5.0 criteria.
According to these criteria, a decreased platelet count is defined as follows: Grade 1 > lower limit of
normal – 75 G/l, Grade 2 < 75G/l – 50 G/l, Grade 3 < 50 G/l – 25 G/l, and Grade 4 < 25 G/l.
oral mucositis
Twenty-two patients who underwent prior haematopoietic stem cell transplantation suffered from
higher grade mucositis. According to the CTCAE v5.0. criteria, oral mucositis is defined as follows:
Grade 1 asymptomatic or mild symptoms, intervention not indicated; Grade 2 moderate pain or
ulcer that does not interfere with oral intake, modified diet indicated; Grade 3 severe pain,
interfering with oral intake; Grade 4 life-threatening consequences, urgent intervention indicated.
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Epistaxis
Epistaxis, as an adverse event due to the procedure, was graded according to CTCAE v5.0. According
to these criteria, bleeding from the nose is defined as follows: Grade 1 mild symptoms, intervention
not indicated; Grade 2 moderate symptoms, medical intervention indicated (e.g., nasal packing,
cauterization, topical vasoconstrictors); Grade 3 transfusion, invasive intervention indicated (e.g.,
hemostasis of bleeding site); Grade 4 life-threatening consequences, urgent intervention indicated.
Antiocoagulation
Anticoagulation means therapeutic anticoagulation with use of intravenous heparin and a targeted
aPTT of 50 – 70 sec..
Statistical analysis
Median values and ranges were used for continuous variables and percentages for categorical
variables. Subgroup analysis on occurrence of side effects was performed using the X2 – test or
Fisher’s exact test for categorical variables and the Wilcoxon or Kruskall Wallis test for continuous
variables depending on compared samples. All statistical tests were two‐sided and a p value of <0.05
was considered statistically significant. Data were analysed using R 3.2.0 statistical software
(http://www.R-project.org).
Results
Baseline characteristics
Fifty-six patients (female: n=26; male: n=30) admitted and treated at the ICU over three years (years
2017-2019) and at high-risk for PP tube placement adverse events due to treatment-induced
thrombocytopenia, therapeutic anticoagulation (aPTT 50 – 70 s.) and treatment-associated oral
mucositis were analysed. Median age was 54.5 (20 - 76) years. All patients were analgo-sedated
(RASS > -2), intubated and mechanically ventilated.
Patients with pre-existing oral mucositis (grade 1, n = 13; grade 2, n=4; grade 3, n=3; grade 4, n=2),
thrombocytopenia (n=56), and pre-existing epistaxis (n=2) received one platelet concentrate prior to
the procedure (n=30). The median platelet count at placement was 26 G/l (range: 4 – 106 G/l).
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Sixteen patients with severe ARDS were referred to veno-venous extracorporal membrane
oxygenation (ECMO). Those patients were put on therapeutic intravenous anticoagulation with a
targeted aPTT of 50 – 70 sec.. None of the patients received antiplatelet agents, warfarin or DOACs.
One patient suffered from v. Willebrands disease. One patient with Child C liver cirrhosis and acute
on chronic liver failure (ACLF) was diagnosed with an INR > 5.0 (INR, international normalized ratio).
Haematology and Oncology
Forty-four patients suffered from haematological/oncological disease. Acute leukaemia was
diagnosed in 22 cases (3 acute lymphatic leukaemias, 19 acute myeloid leukaemias), lymphoma in 8
cases (two Hodgkin lymphomas, 4 diffuse large B-cell lymphoma, 3 T-cell non-Hodgkin lymphoma,
and one mantle cell lymphoma), 3 cases of multiple myelomas, and one case of CML and CMML,
each. The remaining patients suffered from solid tumors. .
Twenty-four patients underwent prior haematopoietic stem cell transplantation (SCT; allogeneic:
n=20, autologous: n=4), 22 of whom (92%) suffered from higher grade mucositis. According to the
EORTC CTCAE v5.0 criteria, mucositis was graduated severe (CTCAE grade 3 and 4) in 5 patients
(23%), whereas 17 patients suffered from mild and moderate mucositis.
Causes for ICU admission
The main cause for ICU admission was acute respiratory distress syndrome (ARDS), most likely
originating from pneumonia. Severe ARDS was found in 28 patients, of whom 16 were referred to
veno-venous ECMO. Prior to ECMO, all 16 patients underwent prone position manoeuvre. In these
patients PP tube placement took place prior to prone position. Nineteen patients fulfilled the criteria
of severe sepsis. Microbiological analysis found pathogens in 39 cases. In the rest fever remained of
unknown origin (FUO).
CEAS procedure – number of attempts, position monitoring and time requirement
Positioning of the nasojejunal tube was successfully performed in all of our high-risk patients in
mean after 1.3 attempts (1st run in 44 patients, 2nd run n = 9, 3rd run n = 2, 4th run n = 1). In addition
to a typical sigmoidal curve on the CORTRAK monitor, placement was confirmed by portable
abdominal x-ray in 44 patients (figures 1 and 2 a, b). X-ray was omitted in the remaining 8 patients,
due to a typical CORTRAK curve, and ability of bile-aspiration. Particularly in patients mechanically
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ventilated in prone position, X-ray guaranteed the successful PP position. The duration of successful
enteral nutrition varied from 2 to 48 days post placement (median 16.5 days).
Excluding all preparation procedures, like logistics, the recording of patients’ data and watering of
the tube, the time required to pass the pylorus and place the feeding tube took a median of 8:30
minutes (1:34 – 23:10 min.). When patients were stratified for mucositis or therapeutic
anticoagulation, no differences were found regarding the placement time (mucositis yes vs
no,p=0.39; anticoagulation yes vs no, p=0.71 (figure 3). Further subgroup analysis revealed no
significant difference between the groups in terms of number of attempts necessary for successful
placement, with a median of 1 (1-4) attempt (figure 3). No patient necessitated endoscopic PP
repositioning.
CEAS procedure - adverse events
Epistaxis was the most frequent adverse event due to the procedure, and was mostly mild (CTCAE
grade 1, n = 27). Medical intervention including nasal packing was indicated in 6 patients (CTCAE
grade 2). Lower platelet count was significantly associated with occurrence of epistaxis (p <0.001)
(figure 4). However, neither the use of therapeutic anticoagulation with heparin (p= 0.49), mucositis
(p=0.45), nor duration (p=0.75) or number of attempts for successful tube placement (p=0.77) had
an impact of the occurrence of bleeding complications. One patient developed self-limiting gastric
haemorrhage (CTCAE grade 1). No further GI-bleeding was seen. Gastric- or bowel perforation did
not occur. Neither pulmonary misplacement, accidental extubation nor other pulmonary
complications (e.g. aspiration) including pneumothorax or pneumonitis as well as hypoxaemia, and
arrhythmia were observed. No lethal complication was seen.
CEAS data are summarized in table 1.
Discussion
So far, endoscopy is the gold standard for insertion of PP feeding tubes (7). However, particularly in
ICU patients compromised by severe thrombocytopenia, therapeutic anticoagulation, and
chemotherapy-induced severe mucositis, endoscopy bears the risk of bleeding and trauma resulting
in perforation during the procedure. Furthermore, transportation of ICU patients to another
department for the intervention may compromise patients safety ultimately resulting in more
operation time be required or postponement of the intervention (6, 24, 25).
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With this analysis, we are the first to show that the use of electromagnetic-guided CEAS for PP
feeding tube placement is feasible, safe and effective in patients with a low platelet count and on
therapeutic anticoagulation on the ICU. Beside such a highly selected study population,CEAS (CEAS;
CORPAK MedSystems, IL, USA) has proven efficacy and safety in numerous studies when performed
by an experienced operator (7-15). A recently published study has shown that, once routine has
been built up half or more patients requiring a naso-duodenal feeding tube would qualify for
Cortrak® placement, and in the same way ICU patients could be considered (8). Despite promising
results, researchers in recent studies have expressed concern that a higher level of user expertise
may be required for safe use. A retrospective study showing the results of more than 6000 PP
feeding tube placements in mostly critically ill patients (83%) stressed out that the continuously
training of the staff is required to avoid serious complications; they reported on 2% pulmonary
deviation complications while we induced none in our high risk cohort (26). Further, in a
retrospective, secondary analysis of the MAUDE database, 54 adverse events between the years of
2006 and 2016 were identified and reviewed related to CORTRAK (8, 9). Most events (98%) involved
erroneous pulmonal feeding tube placement. Pulmonal complications included pneumothorax (77%)
and pneumonitis (21%). Death occurred in 17% of pulmonal placements. Unfortunately, clinicians
failed to recognize placement in 89% of CORTRAK insertion tracings reviewed. The authors conclude,
that pulmonal placement is not unique to CORTRAK and is an inherent risk of all feeding tube
insertions. Therefore, clinicians must observe closely for lung placement and discriminate lung from
gastric placement on insertion tracings. Moreover, clinicians require specialized training and
experience to develop competency in using the CORTRAK device (9). Another prospective,
observational pilot study has shown that confidence with the CORTRAK tracing was estimated to
require at least ten feeding tube insertions. The authors concluded that interpretation of correct
positioning can be challenging and therefore requires multiple successful attempts to gain enough
competency and confidence for this intricate skill-set (10). In our study cohort pulmonal
misplacement and consecutive pulmonal complications could be totally avoided, and no gut
perforation occurred when performed by an experienced operator.
Recent data show that EM-guided PP feeding tube placement can be carried out successfully in a
high proportion of patients (70%-91%) taking in mean 11 to 42 minutes and 1.2 attempts. It is of
note that despite of the high-risk profile of our patient cohort success rate was 100 %, taking in
mean 8.30 minutes while number of attempts was similar to the previously reported. Once again,
this finding emphasise the argument of experience and consequently staff training to realise PP tube
placement quickly, successfully and safely in critically ill patients with coagulopathies.
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In general, CEAS guided feeding tube placement related complications were reported in 3-18% with
nose bleeding or gastro-intestinal bleeding occurring in 3,8% to 18% or 0.3%, respectively (16, 24).
Pre-existing epistaxis was considered as contraindication in those studies (25). In the light of the
high-risk constellation for severe bleeding events in our cohort, the risk of severe bleeding was
negligible little when using CEAS for establishing nasojejunal EN. Clearly, a relatively high overall rate
of epistaxis was noted in these high-risk patients, but at a low grade (CTCAE grade 1, 37.5%). Medical
intervention was only indicated in six patients (CTCAE grade 2, 10.7%), consisting solely of nasal
packing while not requiring additional critical interventions. Taking into account the low median
thrombocyte count of 26 G/l, and existing additional risk factors for bleeding due to mucositis or
simultaneous intravenous anticoagulation in patients during ECMO, this adverse event is definitively
manageable. Further bleeding reduction could be obtained by substitution of more than one platelet
concentrate prior to the start of the procedure. However, it is not surprisingly that bleeding
complications were more frequently seen in our patients as compared to others, but it is remarkable
that no severe bleeding complication was noted (16, 24, 25). The low rate of serious adverse events
and the complete absence of lung complications are probably due to the fact, that all CEAS
placements were undertaken without exception by one single intensivist with vast experience of
CEAS placements. We therefore absolutely agree with the authors mentioned above, that CEAS
placements in such a high-risk population must be definitively reserved to an experienced operator.
Our analysis is hampered by low sample size, and its single centre and retrospective character. An
unintended selection bias is an inherent risk of retrospective studies. We therefore reported on all
patients matching the inclusion criteria treated in the above given period of time. Data quality is high
as patient charts give detailed inside in patients’ treatment course and their complications.
Considering operator pitfalls and patient risks, CEAS has proven efficicacy and safety when
placement is performed by such an experienced physician (7-15). Abdominal, contrast enhanced X-
ray is indicated in cases of uncertain tube positioning, particularly in patients ventilated mechanically
in prone position. Moreover, our analysis shows, that CEAS can safely be extended to patients with
chemotherapy-induced mucositis, severe thrombocytopenia and simultaneous therapeutic
anticoagulation during ECMO.
Conclusion
This single institutional study allows the conclusion, that CEAS performed by an experienced
operator for many years, seems to be a simple, safe and rapidly available bedside tool for placing PP
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tubes also in thrombocytopenic and simultaneously anticoagulated critically ill patients not bearing
the risk of severe complications. A prospective study is in preparation.
Disclosure statement
The authors declare that they have no conflict of interest. This research did not receive any specific
grant from funding agencies in the public, commercial or not-profit sectors.
Authors´ contribution
S. S. Stecher, H. J. Stemmler and A. Fraccaroli equally contributed to the conception and design of
the research; M. Barnikel, H. Drolle, A. Pawlikowski contributed to the design of the research; H. J.
Stemmler, J. Tischer, T. Weiglein, A. Alig and S. Anton contributed to the acquisition and analysis of
the data; S. S. Stecher, H. J. Stemmler and A. Fraccaroli contributed to the interpretation of the data;
and J. Tischer, A. Fraccaroli and H. J. Stemmler drafted the manuscript. All authors critically revised
the manuscript, agree to be fully accountable for ensuring the integrity and accuracy of the work,
and read and approved the final manuscript.
Clinical relevancy statement
Enteral nutrition via a postpyloric tube reduces several risks like nosocomial pneumonia and
aspiration, but necessitates endoscopy for reliable placement. Endoscopic insertion carries
implications on patient safety issues, which are of importance, particularly in patients comprised by
thrombocytopenia and/or on anticoagulants, or patients suffering from severe mucositis due to anti-
neoplastic treatments. Cortrak enteral access system (CEAS) has been reported to be a promising
bedside tool for placing a PP feeding tube. Our data showed that CEAS is safe and successful also in
thrombocytopenic and simultaneously anticoagulated critically ill patients, not bearing the risk of
severe complications when performed by an experienced operator.
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Table 1: patient data and CEAS efficacy and adverse events
Group
(subgroup)
n
platelet count
median (range) [G/l]
PC
transfusio
n (n)
Therapeutic
Anticoagulation
(n.)
CEAS
trials
[n]
med
ian
tim
e
[min
.] *
Dura
tion
of
EN
[days
]
AE
epist
axis
[grad
e]
1
2
3
4
1
2
3
4
Study
populatio
n
5
6
26 (4-106)
30
16
44
9
2
1
08:3
0
16,5
27
6
-
-
Haematoo
ncology
4
4
26 (4-106)
30
10
34
7
2
1
08:5
0
16
20
-
-
-
SCT
2
4
21 (4-106)
21
3
19
3
1
1
08:3
0
17
14
-
-
-
vvECMO
1
0
29 (4-99)
8
10
5
3
1
1
07:3
7
16
6
3
-
-
vvECMO
1
6
29 (4-99)
8
16
11
3
1
1
07:3
7
17
6
-
-
-
SCT
3
19 (4-21)
3
3
1
-
1
1
07:3
5
16
2
3
-
-
Others #
6
48 (26-105)
-
6
5
1
-
-
04:1
3
14
1
-
-
-
Comment: whole study population n= 56; overlapping groups and subgroups
abbr.: PC, platelet concentrate; therapeutic anticoagulation, heparin with aPTT 50 – 70 s; CEAS, Cortrak enteral access system; AE, adverse
events (epistaxis CTCAE grade); time *, exclusively all preparation procedures (in case of multiple trials, time of the successful trial); EN,
enteral nutrition ; # cystic fibrosis (n=2), interstitial lung disease, pulmonary thromboembolism, pancreatitis, lymphangioleiomyomatosis
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Fig. 1: confirmation of correct placement by portable abdominal x-ray with contrast material (10 ml
GASTROGRAFIN 76%, Bayer Vital) - pat. no. 35, 65 year old female, AML, sepsis, pneumonia,
metapneumovirus
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Fig. 2 a: CEAS screenshot (grayscale) after successful placement of the postpyloric tube - pat. no. 20,
62 year old male, CMML, sepsis (candida albicans)
A – C anterior view: A, esophageal passage; B, gastric passage; C transpyloric & duodenal passage; a – b depth cross section: a,transhiatal
passage from esophagus to intraperitoneal stomach; b, transpyloric passage into duodenum
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Fig. 2 b: confirmation of correct placement by portable abdominal x-ray with contrast material (10
ml GASTROGRAFIN 76%, Bayer Vital) - pat. no. 20, 62 year old male, CMML, sepsis (candida
albicans)
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