UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054430 |
|---|---|
| Receipt number | R000052739 |
| Scientific Title | Association between the stomach position and the success rate after the second or more attempt for placement of feeding tube |
| Date of disclosure of the study information | 2024/05/19 |
| Last modified on | 2024/10/01 23:25:03 |
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Basic information
Public title
Association between the stomach position and the success rate after the second or more attempt for placement of feeding tube
Acronym
Association between the stomach position and the success rate after the second or more attempt for placement of feeding tube
Scientific Title
Association between the stomach position and the success rate after the second or more attempt for placement of feeding tube
Scientific Title:Acronym
Association between the stomach position and the success rate after the second or more attempt for placement of feeding tube
Region
| Japan |
Condition
Condition
Patients admitted to Intensive Care Unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients undergoing post-pyloric enteral feeding tube placement in the intensive care unit, the purpose of this study is to examine the association between the stomach position assessed by abdominal radiograph or CT taken before the placement and the success rate of second or subsequent placement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between the stomach position aassessed by abdominal radiograph or CT taken before the placement and the success rate of second or subsequent placement.
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 requiring enteral nutrition after admission to the intensive care unit
Patients who have a new blind enteral feeding tube inserted after admission to the ICU or who require replacement of an indwelling enteral feeding tube (regardless of its position)
Patients with failure of initial FT placement
Key exclusion criteria
Postoperative patients with an enteral feeding tube placed or a surgical enteral feeding route (gastrostomy, enterostomy) secured prior to admission
Patients for whom enteral nutrition is not indicated (e.g., ileus, intestinal ischemia, gastrointestinal bleeding, refractory diarrhea, gastrointestinal infections, etc.)
Target sample size
400
Research contact person
Name of lead principal investigator
| 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
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
yokose_p12@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
Independent Ethics Committee of Yokohama City University
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
+81453707627
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
| 2024 | Year | 05 | Month | 19 | 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
288
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Covariates
Factors of disease
1) SOFA score
2) Surgical patient
3) Internal Medicine patient
Factors of Patients
4) Age 5) Gender 6) Height 7) BMI 8) Bowel sound level 9) Diabetes 10) Position of stomach 11) Body position at the procedure 12) Water balance 13) Albumin 14) Enteral feeding tube position at first unsuccessful placement
Drug and medical devices
15) prokinetic agents
16) vasopressor
17) sedatives
18) opioid
19) cardiac assistance device (ECMO, IABP, or VAD)
20) Renal replacement therapy
21) Experience level of the physicians
Characteristics of patients
Diagnosis
VFD
Definition of success of enteral feeding tube placement
-Confirming the tube tip into the duodenum by abdominal radiographs taken just after the placement of enteral feeding tube
Statistical analysis
Primary outcome
Logistic regression analysis
Variable selection will be performed using the LASSO with the factors mentioned above as covariates. The position, gender, age, and BMI will be forced entry into the analysis.
Secondary analysis of primary outcome
Perform logistic regression analysis using the location of the stomach as assessed on CT images.
Secondary outcomes:
Logistic regression analysis considering intraindividual correlations for covariate adjustment for the success or failure of all blind post pyloric FT placement
Create a ROC curve for the estimated gastric curvature position and successful enteral feeding tube insertion, and calculate the AUC and CI using the Delong method.
After creating data divided into two groups with and without gastroptosis based on the obtained cutoff value, multivariate analysis will be performed similar to the analysis of the primary endpoint.
The angle between the line connecting the gastric horn and pylorus and the descending duodenum in the pre-insertion CT, and the height from the gastric horn to the pylorus
Using Spearman's rank correlation coefficient.
Management information
Registered date
| 2024 | Year | 05 | Month | 18 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052739
