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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Pneumoperitoneum

Treatments: Procedure: CO2 insufflation; Procedure: Ambient air insufflation

Study type: Interventional

Funder types: Other

Identifiers

NCT02619656

55102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Treatment

Experimental group

Description:

Patients randomized to insufflation with CO2. Intervention: CO2 Insufflation with CO2Efficient Endoscopic Insufflator on managed flow setting at 3.4 L/min

Treatment:

Procedure: CO2 insufflation

Control

Active Comparator group

Description:

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

Treatment:

Procedure: Ambient air insufflation