A Trial of Supplemental CO2 Versus Room Air in Percutaneous Endoscopic Gastrostomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02619656|
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pneumoperitoneum||Procedure: CO2 insufflation Procedure: Ambient air insufflation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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
- 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.
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
|United States, Utah|
|University of Utah SOM|
|Salt Lake City, Utah, United States, 84132|
|Study Chair:||Christopher Murphy, MD||University of Utah SOM|
|Principal Investigator:||John C Fang, MD||University of Utah SOM|