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

NCT04541667 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-10-10

Study results available
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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.

Conditions

  • Endoscopy

Interventions

OTHER

Air

Air will be used for luminal inflation.

OTHER

Carbon Dioxide

Carbon dioxide will be used for luminal inflation.

Sponsors & Collaborators

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

    collaborator OTHER

  • University of Nebraska

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2021-07-31
Completion
2022-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04541667 on ClinicalTrials.gov