Back to resultsA Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy
Primary Purpose
Pneumoperitoneum
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO2 insufflation
Ambient air insufflation
Sponsored by
About this trial
This is an interventional prevention trial for Pneumoperitoneum focused on measuring PEG, CO2 insufflation, Room Air insufflation, pneumoperitoneum
Eligibility Criteria
Inclusion Criteria:
- Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy
Exclusion Criteria:
- None
Sites / Locations
- University of Utah SOM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
Patients randomized to insufflation with CO2. Intervention: CO2 Insufflation with CO2Efficient Endoscopic Insufflator on managed flow setting at 3.4 L/min
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
Outcomes
Primary Outcome Measures
Post-procedure pneumoperitoneum
Frequency of post pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement.
Secondary Outcome Measures
Full Information
NCT ID
NCT02619656
First Posted
November 10, 2015
Last Updated
November 30, 2015
Sponsor
University of Utah
1. Study Identification
Unique Protocol Identification Number
NCT02619656
Brief Title
A Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy
Official Title
Insufflation With Carbon Dioxide Reduces Pneumoperitoneum After Percutaneous Endoscopic Gastrostomy (PEG): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumoperitoneum
Keywords
PEG, CO2 insufflation, Room Air insufflation, pneumoperitoneum
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients randomized to insufflation with CO2.
Intervention: CO2 Insufflation with CO2Efficient Endoscopic Insufflator on managed flow setting at 3.4 L/min
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
CO2 insufflation
Other Intervention Name(s)
CO2Efficient Endoscopic Insufflator on flow setting 3.4L/min
Intervention Description
Patients were randomized to insufflation with CO2.
Intervention Type
Procedure
Intervention Name(s)
Ambient air insufflation
Other Intervention Name(s)
Evis Exera 111 CLV-190 on medium air flow setting 0.68L/min
Intervention Description
Patients were randomized to insufflation with ambient air.
Primary Outcome Measure Information:
Title
Post-procedure pneumoperitoneum
Description
Frequency of post pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement.
Time Frame
left-lateral decubitus abdominal x-rays 30 min after PEG placement.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Murphy, MD
Organizational Affiliation
University of Utah SOM
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John C Fang, MD
Organizational Affiliation
University of Utah SOM
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah SOM
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy
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