Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant (ETCO2)

University of Nebraska

Status: Completed

Conditions: Endoscopy

Treatments: Other: Air; Other: Carbon Dioxide

Study type: Interventional

Funder types: Other

Identifiers

NCT04541667

0632-19-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 6 months to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Air for luminal inflation

Active Comparator group

Description:

Patients randomized into this arm will have luminal inflation using air.

Treatment:

Other: Air

Carbon Dioxide for luminal inflation

Active Comparator group

Description:

Patients randomized into this arm will have luminal inflation using carbon dioxide.

Treatment:

Other: Carbon Dioxide