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Safety and Efficacy of CO2 for Endoscopy

NCT03287687 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-01-19

Study results available
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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.

Conditions

  • Endoscopy
  • Insufflation

Interventions

DRUG

Carbon dioxide (CO2) gas insufflation

CO2 gas use for insufflation during endoscopy instead of air insufflation

DRUG

Air insufflation

Air insufflation is the standard of practice (used in the control arm)

Sponsors & Collaborators

  • Warren Bishop

    lead OTHER

Principal Investigators

  • Warren P Bishop, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2019-04-09
Completion
2019-04-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03287687 on ClinicalTrials.gov