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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | CO2 insufflation | Patients were randomized to insufflation with CO2. |
| PROCEDURE | Ambient air insufflation | Patients 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.