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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: University of Utah

Current Primary Outcome: Post-procedure pneumoperitoneum [ Time Frame: left-lateral decubitus abdominal x-rays 30 min after PEG placement. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Utah

Dates:
Date Received: November 10, 2015
Date Started: April 2012
Date Completion:
Last Updated: November 30, 2015
Last Verified: November 2015