A Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy

November 30, 2015 updated by: John C. Fang, M.D., University of Utah

Insufflation With Carbon Dioxide Reduces Pneumoperitoneum After Percutaneous Endoscopic Gastrostomy (PEG): A Randomized Controlled Trial

The investigators hypothesize that using carbon dioxide for PEG placement versus using room air will decrease post-procedure pneumoperitoneum as well as improve post-procedure bloating/pain, and waist circumference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and study aims: Pneumoperitoneum following PEG placement has been reported in up to 60% of cases, and while usually benign and self-limited, it can lead to evaluation for suspected perforation. This study was designed to determine whether using CO2 compared to ambient air for insufflation during PEG reduces post-procedure pneumoperitoneum.

Patients and Methods: Prospective, double blind, randomized trial of 35 consecutive patients undergoing PEG at a single academic medical center. Patients were randomized to insufflation with CO2 or ambient air. Primary outcome was pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement. Secondary endpoints included abdominal distention, pain, and bloating.

Study Type

Interventional

Enrollment (Actual)

35

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
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah SOM

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy

Exclusion Criteria:

  • None

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment

Patients randomized to insufflation with CO2.

Intervention: CO2 Insufflation with CO2Efficient Endoscopic Insufflator on managed flow setting at 3.4 L/min
Procedure: CO2 insufflation
Patients were randomized to insufflation with CO2.
Other Names:
  • CO2Efficient Endoscopic Insufflator on flow setting 3.4L/min
Active Comparator: Control

Patients randomized to insufflation with ambient air.

Intervention: Ambient air insufflation with Evis Exera 111 CLV-190 on medium air flow setting 0.68 L/min
Procedure: Ambient air insufflation
Patients were randomized to insufflation with ambient air.
Other Names:
  • Evis Exera 111 CLV-190 on medium air flow setting 0.68L/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-procedure pneumoperitoneum
Time Frame: left-lateral decubitus abdominal x-rays 30 min after PEG placement.
Frequency of post pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement.
left-lateral decubitus abdominal x-rays 30 min after PEG placement.

Collaborators and Investigators

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

Sponsor

University of Utah

Investigators

  • Study Chair: Christopher Murphy, MD, University of Utah SOM
  • Principal Investigator: John C Fang, MD, University of Utah SOM

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

April 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 10, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55102

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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