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

Not Applicable

Completed

• Conditions: Pneumoperitoneum
• Interventions: Procedure: CO2 insufflation; Procedure: Ambient air insufflation

• Registration Number: NCT02619656
• Lead Sponsor: University of Utah

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-11
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2015-11-30
• Last Update Submitted: 2015-11-30
• Study First Posted: 2015-12-02
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy

Read More

Exclusion Criteria

• None

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	CO2 insufflation	Patients randomized to insufflation with CO2. Intervention: CO2 Insufflation with CO2Efficient Endoscopic Insufflator on managed flow setting at 3.4 L/min
Control	Ambient air insufflation	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

Primary Outcome Measures

Name	Time	Method
Post-procedure pneumoperitoneum	left-lateral decubitus abdominal x-rays 30 min after PEG placement.	Frequency of post pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement.

Trial Locations

Locations (1)

University of Utah SOM; 🇺🇸 Salt Lake City, Utah, United States