UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054745 |
|---|---|
| Receipt number | R000062560 |
| Scientific Title | In post-pyloric placement of feeding tube,Enteral Access System (EAS) guided placement versus fluoroscopic placement:a randomized single center trial |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/12/24 11:00:06 |
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Basic information
Public title
Evaluation of the usefulness of Enteral Access System (EAS) for post-pyloric feeding tube placement
Acronym
Evaluation of the usefulness of Enteral Access System (EAS) for post-pyloric feeding tube placement
Scientific Title
In post-pyloric placement of feeding tube,Enteral Access System (EAS) guided placement versus fluoroscopic placement:a randomized single center trial
Scientific Title:Acronym
In post-pyloric placement of feeding tube,Enteral Access System (EAS) guided placement versus fluoroscopic placement:a randomized single center trial
Region
| Japan |
Condition
Condition
A hospitalized patient with intestinal intolerance in our ICU
Age at registration is 16 years or older
Written consent for participation in the study has been obtained from the research subjects
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Enteric Access System (EAS) allows real-time confirmation of the position of the distal end of a gastric tube, making it potentially useful for successful post-pyloric placement. Reports on the effectiveness of EAS-guided post-pyloric tube placement are sporadic. Compared to methods using endoscopy or fluoroscopy, the EAS method is believed to be advantageous as it can be performed at the bedside without the need for patient transport, and is considered less invasive. This study aims to compare the success rates and time to successful placement between the EAS method and the conventional fluoroscopy-guided insertion method, evaluating the usefulness of the EAS method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The success rate of post-pyloric placement within 20 minutes
Key secondary outcomes
Time to successful post-pyloric placement
Rate of complications
Radiation exposure time
Healthcare economic considerations
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Fluoroscopy-guided group:
Patients are transferred from the ICU to the operating room for the procedure.
Time elapsed from insertion of the enteral feeding tube until confirmation of correct tube placement is measured.
Time taken for patient transfer between the ICU and the operating room is also measured.
Fluoroscopy exposure time (X-ray) is measured.
Interventions/Control_2
EAS group:
Conducted at the ICU bedside.
Uses CORTRAK2, marketed by Terumo Corporation.
Measures the time from insertion of the enteral feeding tube until confirmation of correct tube position on the monitor.
Success is confirmed if post-pyloric placement is verified by X-ray after insertion.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A hospitalized patient with intestinal intolerance in our ICU
Age at registration is 16 years or older
Written consent for participation in the study has been obtained from the research subjects
Key exclusion criteria
Patients under 16 years of age.
Patients for whom warnings, contraindications, and prohibitions regarding the medical device (CORTRAK2) used in the EAS method apply.
Patients with a history of head and neck or upper gastrointestinal surgery.
Patients suspected of having esophageal hiatus hernia based on prior imaging studies, making gastric tube insertion difficult.
*Other patients deemed unsuitable for safe implementation of this study by the principal investigator or attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | osamu |
| Middle name | |
| Last name | umegaki |
Organization
Osaka Medical and Pharmaceutical University
Division name
Intensive Care Unit (ICU)
Zip code
569-8686
Address
2-7 daigaku,takatuki,osaka,japan
TEL
072-683-1221
osamu.umegaki@ompu.ac.jp
Public contact
Name of contact person
| 1st name | sho |
| Middle name | |
| Last name | tomihata |
Organization
Osaka Medical and Pharmaceutical University
Division name
Intensive Care Unit (ICU)
Zip code
569-8686
Address
2-7 daigaku,takatuki,osaka,japan
TEL
072-683-1221
Homepage URL
sho.tomihata@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical 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
Osaka Medical and Pharmaceutical University
Address
2-7 daigaku,takatuki,osaka,japan
Tel
072-683-1221
rco000@ompu.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 | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 24 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062560
