N/A
N=200
Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant
Endoscopy
Bottom Line
View on ClinicalTrials.gov: NCT04541667 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Number of Procedures With Elevated End-tidal CO2 Levels — 8; 21 Procedures
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Air (Other); Carbon Dioxide (Other)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Procedures With Elevated End-tidal CO2 Levels |
8; 21 | — |
| SECONDARY Number of Participants Reporting Abdominal Pain |
14; 15 | — |
Summary
During the course of an endoscopic procedure, air has historically been used to inflate the lumen to provide adequate visualization and allow for the endoscope to advance as necessary. In many adult centers, carbon dioxide is used for insufflation for all procedures. Many pediatric centers have started using carbon dioxide for insufflation during endoscopy based on the adult studies. Few pediatric studies have been done. This study is designed to test whether carbon dioxide is associated with any negative, post-procedural, outcomes in pediatric patients.
Eligibility Criteria
Inclusion Criteria
- Children 6 months to 19 years old and
- Undergoing upper endoscopy at Children's Hospital & Medical Center in Omaha, NE and
- Parents or legal guardians consent to the study
Exclusion Criteria
- Patients and legal guardians who decline participation in the study
- Patients with chronic respiratory disease (defined as severe asthma, bronchopulmonary dysplasia and cystic fibrosis-related pulmonary disease)
- Patients with cyanotic heart disease
- Patients with an ASA status of ≥ 3.
- Patients who are wards of the state or in foster care
- Prisoners
- Patients undergoing colonoscopy only procedures or procedures not related to upper endoscopy
Data sourced from ClinicalTrials.gov (NCT04541667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.