UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051071 |
|---|---|
| Receipt number | R000058239 |
| Scientific Title | Evaluation of Non-Inferiority of Nasogastric Feeding Tube Placement in Critically Ill Patients Using CORTRAK as an Enteral Feeding Tube Insertion Tracking Device and Assessment of Safety |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/11/14 09:14:59 |
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Basic information
Public title
Evaluation of the Safety of Feeding Tube Placement in Critically Ill Patients Using an Enteral Feeding Tube Insertion Tracking Device
Acronym
Non-inferiority verification of nasogastric tube placement in critically ill patients using the coat rack method
Scientific Title
Evaluation of Non-Inferiority of Nasogastric Feeding Tube Placement in Critically Ill Patients Using CORTRAK as an Enteral Feeding Tube Insertion Tracking Device and Assessment of Safety
Scientific Title:Acronym
Non-inferiority verification of nasogastric tube placement in critically ill patients using the coat rack method
Region
| Japan |
Condition
Condition
(1) Inclusion Criteria
All of the following criteria are met
Patients admitted to the ICU
Age 18 years and older
Patients requiring enteral nutrition via nasogastric feeding tube
Patients who are able to insert the tube in a supine position
Patients who have obtained consent to participate in this study from the patients themselves or their surrogates
Classification by specialty
| Emergency medicine | Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the non-inferiority of nasogastric feeding tube placement using the nurse's enteral feeding tube insertion tracking device (hereafter referred to as the CORTRAK method) versus the physician's blind method for success rate in patients admitted to the ICU requiring enteral feeding via nasogastric feeding tube, and to evaluate safety in addition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of nasogastric tube placement in the gastric
Key secondary outcomes
Implantation time, location of implantation, medical economics, complications and safety, learning curve for training period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Control: Blind method
The nasogastric feeding tube is placed in the ICU by up to 10 specific physicians collaborating in the study. Intragastric placement will be confirmed by radiographs taken with a portable X-ray machine on the same day after the nasogastric feeding tube is placed. Twenty consecutive cases will be evaluated during the day shift hours when the specific physician collaborating in the study is on duty.
Interventions/Control_2
Intervention: CORTRAK Method
Using the CORTRAK (Approval Number: 22800BZX00142000), the first safe enteral feeding tube insertion tracking device approved by the U.S. FDA (attached), up to four specifically trained nurses with at least 5 years of ICU experience collaborating in the study will place a nasogastric feeding tube in the ICU under physician supervision. The specific training will be performed using a simulator. The specific training will consist of a simulated training period using a simulator and four consecutive experiences of placing the tube under the supervision of a physician, and only nurses who have completed this period will place the tube.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Selection Criteria
All of the following criteria are met
Patients admitted to the ICU
Age 18 years and older
Patients requiring enteral nutrition via nasogastric feeding tube
Patients who are able to insert the tube in the supine position
Patients who are able to insert the tube in a supine position
Patients who have obtained consent to participate in this study from the patient or a surrogate
Key exclusion criteria
Exclusion Criteria
Patients are excluded if any of the following criteria are met
Esophageal varices
Previous upper gastrointestinal surgery (oropharynx, esophagus or stomach)
History of upper gastrointestinal stenosis or obstruction
Patients to whom warnings and contraindications/prohibitions apply (patients with implanted ventricular assist device (VAD), electrically powered medical devices)
Patients with a need for tube placement outside of day shift hours
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Sakuramoto |
Organization
Japanese Red Cross Kyushu International College of Nursing
Division name
Department of Critical Care and Disaster Nursing
Zip code
811-4157
Address
1-1 asty, Munakata, Fukuoka, Japan
TEL
0940-35-7001
gongehead@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Sakuramoto |
Organization
Japanese Red Cross Kyushu International College of Nursing
Division name
Department of Critical Care and Disaster Nursing
Zip code
8114157
Address
1-1 asty, munakata city
TEL
0940-35-7001
Homepage URL
gongehead@yahoo.co.jp
Sponsor or person
Institute
Japanese Red Cross Kyushu International College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Kyushu International College of Nursing
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 Review Board of the Japanese Red Cross Kyushu International College of Nursing
Address
1-1 asty, munakata city
Tel
0940-35-7001
gongehead@yahoo.co.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
| 2023 | Year | 06 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058239
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| Registered date | File name |
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