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NCT Number: NCT06134154

Safety and Efficacy of Carbon Dioxide Gas for Endoscopy

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.

Recruiting

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Key information

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Chinenye R Dike, MD

CONTACT

[email protected]

3345585519

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic insufflation gas

Other

Carbon dioxide gas versus air for endoscopic insufflation

Primary outcomes

  1. Abdominal Pain

    Time frame: baseline/ pre-procedure to immediately after the procedure

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

Secondary outcomes

  1. PCO2 level

    Time frame: baseline/ preprocedural to immediately after the procedure

    Incidence of elevated carbon dioxide level in the blood from pre-procedure to post -procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Chinenye R Dike, MD MS

CONTACT

[email protected]

205 638 9918

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 18, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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