Clinical Trials Directory

Trials / Completed

CompletedNCT02619656

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECO2 insufflationPatients were randomized to insufflation with CO2.
PROCEDUREAmbient air insufflationPatients were randomized to insufflation with ambient air.

Timeline

Start date
2012-04-01
Primary completion
2015-06-01
Completion
2015-06-01
First posted
2015-12-02
Last updated
2015-12-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02619656. Inclusion in this directory is not an endorsement.