NCT04541667

Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 6 Months – 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Luminal inflation is essential for adequate visualization and endoscope advancement during endoscopy. Although air has previously been the standard gas used, CO2 is increasing preferred in adult endoscopy centers, due to reports of decreased post-procedural abdominal discomfort compared to air. Few published studies in children demonstrated decreased abdominal discomfort with use of CO2, but safety concerns for its use in pediatric endoscopy remain. This is a Double-blinded, prospective, randomized study of all pediatric patients undergoing procedures involving upper endoscopy in the Childrens Hospital \& Medical Center. Randomization will be for patients undergoing upper endoscopy related procedures. Patients will be randomized 1:1 for air or CO2. Vital signs will be recorded before the procedure, throughout the procedure and after the procedure until fully awake. While in the procedure room, end-tidal CO2 level will be continuously recorded.

Conditions

• Endoscopy

Interventions

Type	Name	Description
OTHER	Air	Air will be used for luminal inflation.
OTHER	Carbon Dioxide	Carbon dioxide will be used for luminal inflation.

Timeline

• Start date: 2019-11-18
• Primary completion: 2021-07-31
• Completion: 2022-05-31
• First posted: 2020-09-09
• Last updated: 2023-10-10
• Results posted: 2023-02-15

Locations

1 site across 1 country: United States