UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057705 |
|---|---|
| Receipt number | R000065938 |
| Scientific Title | Carbon dioxide versus room air for upper gastrointestinal endoscopy under intravenous anesthesia |
| Date of disclosure of the study information | 2025/04/24 |
| Last modified on | 2025/04/24 12:13:44 |
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Basic information
Public title
Carbon dioxide versus room air for upper gastrointestinal endoscopy under intravenous anesthesia
Acronym
Carbon dioxide insufflation in pediatric UGI endoscopy
Scientific Title
Carbon dioxide versus room air for upper gastrointestinal endoscopy under intravenous anesthesia
Scientific Title:Acronym
Carbon dioxide insufflation in pediatric UGI endoscopy
Region
| Japan |
Condition
Condition
pediatric patients indicated for upper gastrointestinal endoscopy
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Upper gastrointestinal endoscopy (EGD) requires insufflation of either carbon dioxide (CO2) or air to allow visualization of the gastrointestinal tract.
In pediatric patients, previous studies evaluating insufflation methods have not measured systemic CO2 concentrations and have used inconsistent sedation protocols, resulting in insufficient evidence.
Therefore, we designed a double-blind randomized controlled trial to compare CO2 and air insufflation in pediatric EGD.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome measures included transcutaneous CO2 (pCO2, mmHg) measured using the TOSCA (transcutaneous blood gas monitoring system), abdominal circumference before and after the procedure, and post-procedural pain assessed using the FLACC pain scale.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
CO2 insufflation group
Interventions/Control_2
air insufflation gourp
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
| Not applicable |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children under 16 years of age undergoing upper gastrointestinal endoscopy as a standalone procedure
Key exclusion criteria
Children with severe motor and intellectual disabilities, chronic respiratory diseases, or cardiac diseases
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Maeyama |
Organization
Osaka Women's and Children's hospital
Division name
Dept of gastroenterology, nutrition and endocrinology.
Zip code
5941101
Address
Murodo-cho840, Isumi city, Osaka.
TEL
0725561220
takatomaeyama@gmail.com
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Maeyama |
Organization
Osaka Women's and Children's hospital
Division name
Dept of gastroenterology, nutrition and endocrinology.
Zip code
5941101
Address
Murodo-cho840, Isumi city, Osaka.
TEL
0725561220
Homepage URL
takatomaeyama@gmail.com
Sponsor or person
Institute
Osaka Women's and Children's hospital
Institute
Department
Personal name
Funding Source
Organization
not applicapable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Women's and Children's hospital
Address
Murodo-cho840, Isumi city, Osaka.
Tel
0725561220
takatomaeyama@gmail.com
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
| 2025 | Year | 04 | Month | 24 | 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
95
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 04 | Month | 24 | Day |
Last modified on
| 2025 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065938
