Safety and Efficacy of CO2 for Endoscopy
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|ClinicalTrials.gov Identifier: NCT03287687|
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : April 18, 2019
Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal distension and discomfort; it is equally effective as air in pediatric patients undergoing endoscopic procedures.
Determine the occurrence and severity of abdominal discomfort and distension associated with endoscopic procedures at baseline, upon awakening from anesthesia, at discharge and at 4 hours after discharge in carbon dioxide group when compared to the air group.
Determine if the expertise level of the endoscopist contributes to abdominal discomfort and distension following endoscopy, and whether this differs in the carbon dioxide group versus air group.
Determine if carbon dioxide is as effective as air for insufflation.
|Condition or disease||Intervention/treatment||Phase|
|Endoscopy Insufflation||Drug: Carbon dioxide gas for insufflation Drug: Air||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blinded, placebo controlled study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
Randomization will be done 1:1, double blinded. - Procedure nurse will randomly choose an envelope from a box; the envelope contains a card listing either "CO2" or "Air". The envelopes will be unmarked and will be prepared with an equal number of cards for each arm. The procedure nurse then turns on either CO2 or air insufflation according to the card in the envelope. The air/CO2 controls will be kept covered to preserve blinding of the endoscopist. She will also record the patient's arm allocation in a logbook, which will be kept in a locked cabinet.
|Official Title:||The Safety and Efficacy of Carbon Dioxide for Insufflation During Endoscopy in Pediatric Patients|
|Actual Study Start Date :||November 27, 2017|
|Actual Primary Completion Date :||April 9, 2019|
|Actual Study Completion Date :||April 9, 2019|
Active Comparator: Air for insufflation
In this arm of patients, air which is currently used as standard of care will be used for insufflation
Air is the standard of practice and will be used in the control arm
Experimental: Carbon dioxide gas for insufflation
in this arm of patients, carbon dioxide (CO2) will be used for insufflation during endoscopy
Drug: Carbon dioxide gas for insufflation
Carbon dioxide gas use for insufflation during endoscopy instead of air
Other Name: CO2
- Change in abdominal pain and distention [ Time Frame: At initial study visit prior to the procedure and within four hours after the procedure ]Abdominal discomfort / pain and distention before and after endoscopy will be compared in both groups
- Is carbon dioxide as effective as air for insufflation [ Time Frame: During procedure ]Endoscopists will be asked to rate the effectiveness of insufflation
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): NCT03287687
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Warren P Bishop, MD||University of Iowa|