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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumoperitoneum

Intervention / Treatment
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* Procedure: CO2 insufflation
* Procedure: Ambient air insufflation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be over the age of 18 and need a percutaneous endoscopic gastrostomy Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients randomized to insufflation with CO2. Intervention: CO2 Insufflation with CO2Efficient Endoscopic Insufflator on managed flow setting at 3.4 L/min | Procedure: CO2 insufflation<br>* Patients were randomized to insufflation with CO2.<br>* Other names: CO2Efficient Endoscopic Insufflator on flow setting 3.4L/min;|
| Active Comparator: Control<br>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 | Procedure: Ambient air insufflation<br>* Patients were randomized to insufflation with ambient air.<br>* Other names: Evis Exera 111 CLV-190 on medium air flow setting 0.68L/min;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedure pneumoperitoneum | Frequency of post pneumoperitoneum determined by left-lateral decubitus abdominal x-rays 30 min after PEG placement. | left-lateral decubitus abdominal x-rays 30 min after PEG placement. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEG, CO2 insufflation, Room Air insufflation, pneumoperitoneum