Safety and Efficacy of Carbon Dioxide Gas for Endoscopy

Safety and Efficacy of Carbon Dioxide Gas for Endoscopic Insufflation in Children

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Pain
• Intervention / Treatment: Other: Endoscopic insufflation gas

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 Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chinenye R Dike, MD MS; Phone Number: 205 638 9918; Email: cdike@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Chinenye R Dike, MD; Phone Number: 334-558-5519; Email: cdike@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Air	Other: Endoscopic insufflation gas; Carbon dioxide gas versus air for endoscopic insufflation
Experimental: Carbondioxide	Other: Endoscopic insufflation gas; Carbon dioxide gas versus air for endoscopic insufflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Pain	Rates of abdominal pain from pre-procedure to immediately after the procedure	baseline/ pre-procedure to immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCO2 level	Incidence of elevated carbon dioxide level in the blood from pre-procedure to post -procedure	baseline/ preprocedural to immediately after the procedure

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: IRB-300011252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No