A Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy
NCT ID: NCT02619656
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2012-04-30
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Treatment
Patients randomized to insufflation with CO2.
Intervention: CO2 Insufflation with CO2Efficient Endoscopic Insufflator on managed flow setting at 3.4 L/min
CO2 insufflation
Patients were randomized to insufflation with CO2.
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
Ambient air insufflation
Patients were randomized to insufflation with ambient air.
Interventions
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CO2 insufflation
Patients were randomized to insufflation with CO2.
Ambient air insufflation
Patients were randomized to insufflation with ambient air.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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John C. Fang, M.D.
Chief, Division of Gastroenterology, Hepatology and Nutrition
Principal Investigators
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Christopher Murphy, MD
Role: STUDY_CHAIR
University of Utah SOM
John C Fang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah SOM
Locations
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University of Utah SOM
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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55102
Identifier Type: -
Identifier Source: org_study_id