Clinical trial NCT04541667: Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant
Official title: Is End Tidal CO2 Level Elevation During Upper Endoscopy With CO2 Gas Insufflation Physiologically Significant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy
Keywords: upper endoscopy
endoscope
abdominal discomfort
insufflation
carbon dioxide
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Medical Center, Omaha, Nebraska
First posted: 2020-09-09
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible study participants will be randomized 1:1 into two study arms; one receiving air and the other receiving carbon dioxide for luminal inflation.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Procedures With Elevated End-tidal CO2 Levels
timeFrame: Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours.
Secondary outcomes:
measure: Number of Participants Reporting Abdominal Pain
timeFrame: This will be assessed before and after the procedure
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
Study officials:
affiliation: Children's Hospital & Medical Center / University of Nebraska Medical Center
name: Chinenye R Dike, MD
role: PRINCIPAL_INVESTIGATOR
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