Comparing carbon dioxide and air for endoscopy in children
Safety and Efficacy of Carbon Dioxide Gas for Endoscopic Insufflation in Children
This study is testing whether using carbon dioxide instead of air during endoscopy can make the procedure safer and more comfortable for children aged 6 months to 18 years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06134154 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of carbon dioxide gas compared to air for insufflation during endoscopic procedures in children aged 6 months to 18 years. Participants will be randomly assigned to receive either CO2 or air during their procedures, and various metrics such as patient comfort, abdominal pain, and vital signs will be recorded before and after the procedures. The study will also monitor end tidal CO2 levels and other relevant demographic and health information to assess the overall impact of the gas used on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include infants and children aged 6 months to 18 years who are scheduled for any upper endoscopic procedure.
Not a fit: Patients with severe chronic lung disease or those classified as ASA Physical Status 4 and above may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved comfort and safety for children undergoing endoscopic procedures.
How similar studies have performed: Other studies have shown promising results in using carbon dioxide for insufflation in endoscopic procedures, suggesting potential benefits in patient comfort.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Chinenye R Dike, MD MS
- Email: cdike@uabmc.edu
- Phone: 205 638 9918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.