NCT06134154

Brief Summary

The goal of this clinical trial is to compare the efficacy and safety of air versus carbon dioxide gas insufflation for endoscopy in children. The main question\[s\] it aims to answer are: •to determine safety of CO2 Assess patient comfort (abdominal pain, flatulence and bloating) with CO2 use when compared to air.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Dec 2028

First Submitted

Initial submission to the registry

October 24, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 24, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4.9 years

First QC Date

October 24, 2023

Last Update Submit

January 21, 2026

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

  • Abdominal Pain

    Rates of abdominal pain from pre-procedure to immediately after the procedure

    baseline/ pre-procedure to immediately after the procedure

Secondary Outcomes (1)

  • PCO2 level

    baseline/ preprocedural to immediately after the procedure

Study Arms (2)

Air

PLACEBO COMPARATOR
Other: Endoscopic insufflation gas

Carbondioxide

EXPERIMENTAL
Other: Endoscopic insufflation gas

Interventions

Endoscopic insufflation gasOTHER

Carbon dioxide gas versus air for endoscopic insufflation

AirCarbondioxide

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- Infants and children 6 months to 18 years undergoing any upper endoscopy related procedure including but not limited to EGD/Colonoscopy, ERCP, EGD only, EUS, EGD with foreign body removal, Enteroscopy.

You may not qualify if:

  • Patients with American Society of Anesthesiology (ASA) Physical Status Classification System of 4 and above
  • Children with chronic lung disease,
  • Children who are wards of the state will be excluded.
  • Children needing language interpreting services that is not Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Central Study Contacts

Chinenye R Dike, MD MS

CONTACT

205 638 9918cdike@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics, Division of Pediatric Gastroenterology, Hepatology and Nutrition

Study Record Dates

First Submitted

October 24, 2023

First Posted

November 18, 2023

Study Start

January 24, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)