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

Not Applicable

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Carbon Dioxide for luminal inflation	Carbon Dioxide	Patients randomized into this arm will have luminal inflation using carbon dioxide.
Air for luminal inflation	Air	Patients randomized into this arm will have luminal inflation using air.

Primary Outcome Measures

Name	Time	Method
Number of Procedures With Elevated End-tidal CO2 Levels	Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours.	Compare the peak end-tidal CO2 levels (\>/= 60 mmHg) observed during endoscopy in children managed with endotracheal intubation or laryngeal mask airway using CO2 versus air

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Abdominal Pain	This will be assessed before and after the procedure	Pain rating scales using FLACC and VAS will be used to assess self reported pain before and after the procedure