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

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ClinicalTrials.gov Identifier: NCT02619656
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
John C. Fang, M.D., 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.

Condition or disease Intervention/treatment Phase
Pneumoperitoneum Procedure: CO2 insufflation Procedure: Ambient air insufflation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Insufflation With Carbon Dioxide Reduces Pneumoperitoneum After Percutaneous Endoscopic Gastrostomy (PEG): A Randomized Controlled Trial
Study Start Date : April 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Treatment

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
Patients were randomized to insufflation with CO2.
Other Name: CO2Efficient Endoscopic Insufflator on flow setting 3.4L/min

Active Comparator: Control

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
Patients were randomized to insufflation with ambient air.
Other Name: Evis Exera 111 CLV-190 on medium air flow setting 0.68L/min




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619656


Locations
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United States, Utah
University of Utah SOM
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Study Chair: Christopher Murphy, MD University of Utah SOM
Principal Investigator: John C Fang, MD University of Utah SOM

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Responsible Party: John C. Fang, M.D., Chief, Division of Gastroenterology, Hepatology and Nutrition, University of Utah
ClinicalTrials.gov Identifier: NCT02619656     History of Changes
Other Study ID Numbers: 55102
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by John C. Fang, M.D., University of Utah:
PEG
CO2 insufflation
Room Air insufflation
pneumoperitoneum

Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases