Safety and Efficacy of Carbon Dioxide Gas for Endoscopy

Not Applicable

Recruiting

• Conditions: Abdominal Pain
• Interventions: Other: Endoscopic insufflation gas

• Registration Number: NCT06134154
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

In this study, children (6 months -18 years) undergoing all endoscopic procedures that includes an upper endoscopy including but not limited to Esophagogastroduodenoscopy (EGD/ upper endoscopy), EGD/ Colonoscopy, Endoscopic Retrograde Cholangiopancreatography (ERCP), Endoscopic ultrasound (EUS) e.t.c after appropriate consent, will be randomized 1:1 to either Air or CO2 gas for endoscopic insufflation. We will record demographics (name, age, sex, MRN, race/ethnicity), anthropometrics including weight, height/length, weight for length (WFL), WFL z score, BMI, BMI z score, indication/ reason for scope, other co-morbidities (other medical problems), personnel involved (faculty only, vs faculty + trainee), minute by minute end tidal CO2 levels, minute by minute minute ventilation levels, baseline blood pCO2, and blood pCO2 after each procedure. Pre and post procedure patient reported abdominal pain, bloating and flatulence. Pre and post procedure nurse assessed pain. Pre and post procedure vital signs. Patients will be randomized using a sealed envelope method by the endoscopy technician. Both patients and providers will be blinded to arm of enrollment.

Study Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-18
• Study Start: 2024-01-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbondioxide	Endoscopic insufflation gas	-
Air	Endoscopic insufflation gas	-

Primary Outcome Measures

Name	Time	Method
Abdominal Pain	baseline/ pre-procedure to immediately after the procedure	Rates of abdominal pain from pre-procedure to immediately after the procedure

Secondary Outcome Measures

Name	Time	Method
PCO2 level	baseline/ preprocedural to immediately after the procedure	Incidence of elevated carbon dioxide level in the blood from pre-procedure to post -procedure

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States