UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036549
Receipt number R000039683
Scientific Title risk factors for difficult postpyrolic intubation of postpyloric enteral feeding tube
Date of disclosure of the study information 2019/04/22
Last modified on 2021/10/09 23:57:50

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Basic information

Public title

risk factors for difficult postpyrolic intubation of postpyloric enteral feeding tube

Acronym

risk factors for difficult postpyrolic intubation of enteral feeding tube

Scientific Title

risk factors for difficult postpyrolic intubation of postpyloric enteral feeding tube

Scientific Title:Acronym

risk factors for difficult postpyrolic intubation of enteral feeding tube

Region

Japan


Condition

Condition

patients who were inserted the post pyloric enteral feeding tube in the intensive care unit

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The object is to explore the risk factors associated with the difficult insertion of the post pyloric enteral feeding tube.

Basic objectives2

Others

Basic objectives -Others

1) the correlation between the ICU length of stay and the number of days from tube insertion start to enteral nutrition start
2) The correlation between the ICU length of the stay and the number of days required to start enteral nutrition

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The odds ratio of the risk factor related to the success rate of the enteral feeding tube insertion

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients diagnosed as requiring the enteral nutrition

The first attempt for insertion or the replacement of the inserted enteral feeding tube

Key exclusion criteria

Patiants wiht gastrostomy or enterocutaneous who do not need the insetion enteral feeding tube
Patients with ileus, severe diarrhea, gastrointestinal bleeding, infection of the gastrointestinal tract

Target sample size

450


Research contact person

Name of lead principal investigator

1st name Masaashi
Middle name
Last name Yokose

Organization

Yokohama city university hospital

Division name

Department of the anesthesiology and critical care medicine

Zip code

2360004

Address

3-9, Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

+81457872800

Email

yokose_p12@yahoo.co.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Yokose

Organization

Yokohama city university hospital

Division name

Department of Anesthesiology and critical care medicine

Zip code

2360004

Address

3-9, Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

+81457872800

Homepage URL


Email

yokose_p12@yahoo.co.jp


Sponsor or person

Institute

Yokohama City University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the institutional ethics committee of Yokohama city university hospital

Address

3-9, Fukuura, Kanazawa-ku, Yokohama

Tel

+81457872800

Email

rinri@yokohama-cu.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 22 Day


Related information

URL releasing protocol

in preparation

Publication of results

Published


Result

URL related to results and publications

https://jintensivecare.biomedcentral.com/articles/10.1186/s40560-021-00577-1

Number of participants that the trial has enrolled

455

Results

Logistic regression analysis:
the position of the greater curvature of the stomach cephalad to L1-L2 was only associated with first pass success
odds ratio 0.62; 95% confidence interval: 0.40-0.95

Results date posted

2021 Year 10 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 10 Month 07 Day

Baseline Characteristics

Age (years) 68 (57-76)
Gender Male 265 (60) Female 177 (40)
Body mass index (kg/m2) 22.4 (19.8-24.9)
SOFA score 10 (7-13)
Diabetes mellitus, n (%) 92 (21)
Renal replacement therapy, n (%) 50 (11)
Use of cardiac assist devices, n (%) 36 (8)
Post-cardiac surgery, n (%) 180 (41)
Hematology, n (%) 43 (10)
Respiratory disease, n (%) 114 (26)

Participant flow

A total of 455 patients were included.
13 patients were excluded (10 patients, EFT was inserted before ICU admission; three patients, a history of upper gastrointestinal surgery)
442 patients met the inclusion criteria.
Final analysis was performed by 414 cases.

Adverse events

Not applicable

Outcome measures

The first-pass success rate: 42.8% (n = 189)
The median ICU length of stay: 8 (6-14) days
VFD: 21 (6-24) days
The number of patients who died in the ICU: 35 (8%)
Logistic regression analysis for the first-pass success rate:
Variables Odds ratio 95% CI P-value
Age 0.91 0.78-1.06 0.22
Sex (female) 1.32 0.74-2.37 0.35
Height 0.91 0.68-1.23 0.55
Fluid balance (each 1-kg increment)
1.04 0.98-1.10 0.18
Serum albumin level (each 1-g/dL increment) 0.74 0.50-1.07 0.11
Position of the stomach (caudal to L1-L2
0.61 0.40-0.94 0.03
Use of sedatives
0.80 0.42-1.55 0.51
Right lateral body position
1.01 0.66-1.53 0.97
Use of prokinetic agents
1.20 0.47-3.07 0.70
Presence of intestinal peristaltic movement 0.75 0.47-1.20 0.23
Renal replacement therapy
0.52 0.26-1.05 0.07
Use of cardiac assist devices
0.86 0.39-2.01 0.77
Post-cardiovascular surgery
0.96 0.58-1.60 0.87

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 12 Month 01 Day

Date of IRB

2018 Year 11 Month 21 Day

Anticipated trial start date

2019 Year 04 Month 22 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Predictive factors
*Factors of disease
1. SOFA (sequential organ failure assessment) Score
2. Post cardiovascular surgery
3. Respiratory disease (ARDS, pneumonia, COPD)
4. Hematologic disease (leukemia, malignant lymphoma, MDS)
*Factors of patients
5. Bowel sound level
6. BMI
7. Diabetes mellitus
8. Gastroptosis
9. Body position
10. Water balance
11. Serum Albumin
12. Age
13. Sex
*Factors of medicine
14. Use of the drug for facilitating the peristalsis
15. Use of the vasopressor
16. ECMO, IABP, LVAD
17. Renal replacement therapy
18. Experience of doctor who tries to insert

Patients characteristics data
diagnosis of disease
dose of the opioids or sedative
gastrointestinal surgery
ventilator free days at 28 days

Outcomes
The success of the initial insertion are
evaluated by the abdominal X-ray imaging immidiately after insertion.

The number of days from starting of enteral feed tube insertion to starting of enteral nutrition

The number of days from entering the ICU to starting of enteral nutrition

The ICU length of stay

Statistics analysis
The logistic regression analysis
Dependent variable: 18 predictive factors
Independent varible: success of the insertion


Management information

Registered date

2019 Year 04 Month 19 Day

Last modified on

2021 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039683


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name