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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04541667
Study type Interventional
Source University of Nebraska
Contact
Status Completed
Phase N/A
Start date November 18, 2019
Completion date May 31, 2022

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