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Completed

NCT Number: NCT02619656

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

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.

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Key information

Conditions

Pneumoperitoneum Digestive System Diseases Peritoneal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah SOM

Salt Lake City, Utah, 84132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

CO2 insufflation

Procedure

Patients were randomized to insufflation with CO2.

Other names: CO2Efficient Endoscopic Insufflator on flow setting 3.4L/min

Ambient air insufflation

Procedure

Patients were randomized to insufflation with ambient air.

Other names: Evis Exera 111 CLV-190 on medium air flow setting 0.68L/min

Primary outcomes

  1. Post-procedure pneumoperitoneum

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 2, 2015
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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