Phase 4
Completed N=178
Safety and Efficacy of CO2 for Endoscopy
Endoscopy · Insufflation
Source: ClinicalTrials.gov NCT03287687 ↗
Enrolled (actual)
178
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Change in Abdominal Distension — 0.9; 0.5; 1.1; 0.9 cm
◆ Published Evidence
Established
25citations · ~3 / year
Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy.
Summary
Hypothesis:
Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal distension and discomfort; it is equally effective as air in pediatric patients undergoing endoscopic procedures.
Aim 1:
Determine the occurrence and severity of abdominal discomfort and distension associated with endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4 hours after discharge in carbon dioxide group when compared to the air group.
Aim 2:
Determine if the expertise level of the endoscopist contributes to abdominal discomfort and distension following endoscopy, and whether this differs in the carbon dioxide group versus air group.
Aim 3:
Determine if carbon dioxide is as effective as air for insufflation.
Linked Publications (2)
-
Randomized, double-blind trial of CO2 versus air insufflation in children undergoing colonoscopy.
-
Is Carbon Dioxide Insufflation During Endoscopy in Children as Safe and as Effective as We Think?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Abdominal Distension |
0.9; 0.5; 1.1; 0.9 | — |
| SECONDARY Elevations of End Tidal Carbon Dioxide |
5; 34 | — |
| SECONDARY Procedures With Post Endoscopy Reported Symptoms |
18; 31; 13; 5; 26; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Pediatric gastroenterology patients aged 6 months through 21 years undergoing endoscopic procedures in the Stead Family Children's Hospital (SFCH) Lower Level 2 procedure room or the operating room in the SFCH who willingly consent/ascent to the study. These procedures will range from Esophagogastroduodenoscopy, Colonoscopy, and those having both Esophagogastroduodenoscopy and Colonoscopy.
Exclusion Criteria
- Non English speaking families who require the services of a translator Children outside the stipulated age range of study. Children in foster care homes or wards of the court. Children and parents who do not willingly consent to the study Children with history of bronchopulmonary dysplasia or other chronic respiratory compromise.
Data sourced from ClinicalTrials.gov (NCT03287687) and the linked publication. 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. Informational only — not medical advice.