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

September 26, 2023 updated by: University of Nebraska
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Children's Hospital & Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Air for luminal inflation
Patients randomized into this arm will have luminal inflation using air.
Other: Air
Air will be used for luminal inflation.
Other Names:
  • Gas
Active Comparator: Carbon Dioxide for luminal inflation
Patients randomized into this arm will have luminal inflation using carbon dioxide.
Other: Carbon Dioxide
Carbon dioxide will be used for luminal inflation.
Other Names:
  • Gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Procedures With Elevated End-tidal CO2 Levels
Time Frame: 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
Measured from time of procedure start to time of procedure conclusion this lasts usually from 1-2.5 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Abdominal Pain
Time Frame: 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
This will be assessed before and after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Children's Hospital and Medical Center, Omaha, Nebraska

Investigators

  • Principal Investigator: Chinenye R Dike, MD, Children's Hospital & Medical Center / University of Nebraska Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2019

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

September 1, 2020

First Submitted That Met QC Criteria

September 8, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0632-19-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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