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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036549
Receipt No. 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 2019/07/27

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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
Institute Yokohama City University School of Medicine
Institute
Department

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
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 12 Month 31 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
2019 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_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


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