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OpenTrials
Completed

NCT Number: NCT04541667

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

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.

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Key information

Conditions

Endoscopy

Age range

6 month–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Air

Other

Air will be used for luminal inflation.

Other names: Gas

Carbon dioxide

Other

Carbon dioxide will be used for luminal inflation.

Other names: Gas

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Children's Hospital and Medical Center, Omaha, Nebraska

Registry information

Acronym: ETCO2

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 9, 2020
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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