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NCT02619656 Clinical Trial

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

Pneumoperitoneum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02619656
Other study ID # 55102
Secondary ID
Status Completed
Phase N/A
First received November 10, 2015
Last updated November 30, 2015
Start date April 2012
Est. completion date June 2015

Study information
Verified date November 2015
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• CO2 insufflation
Patients were randomized to insufflation with CO2.
• Ambient air insufflation
Patients were randomized to insufflation with ambient air.

Locations
Country Name City State
United States University of Utah SOM Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. No
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