CO2 Versus Air Insufflation for Single-balloon Enteroscopy
|Intubation Depth||Device: CO2 insufflation regulator Device: Air insufflation||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
|Official Title:||CO2 Versus Air Insufflation for Single-balloon Enteroscopy: a Randomized, Controlled Trial|
- Intubation Depth [ Time Frame: Within 5 minutes after the examination ]
- Total Enteroscopy Rate [ Time Frame: Within 1 week after all the examinations are finished ]
- Diagnostic Rate [ Time Frame: Within 1 week after all the examinations are finished ]
- Patient's Acceptability [ Time Frame: 6 hours after the examination ]Acceptability was recorded on a questionnaire given to patients after the examination. Patients assessed the degree of abdominal pain/distention along a 10-cm line of the VAS(visual analogue scale), with the 0-cm point labeled "no pain/distention" on left end and the 10-cm point labeled "very severe pain/distention that cannot be tolerated" on the right end. Patients were asked to score the severity of pain/distention experienced at 1, 2, 3 and 6 hours after the completion of the entire examination.
- Procedure Time [ Time Frame: Within 5 minutes after the examination ]
- Abdominal Circumference [ Time Frame: 10 minutes before/after the examination ]To measure abdominal circumference, a tape was placed horizontally around the abdomen at the level of the middle location between the level of anterior superior iliac spine and the lower edge of costal arch, and the measurement was made at the end of a normal expiration before and after the procedure.
- Complication Rate [ Time Frame: Within 1 week after all the examinations are finished ]
|Study Start Date:||July 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Air insufflation regulator
Room air will be used for insufflation as the Active Comparator arm
Device: Air insufflation
The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
Experimental: CO2 insufflation regulator
Device: CO2 insufflation regulator
Device: CO2 insufflation regulator
The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
Currently, air is more frequently used to insufflate gas into the lumen to ensure the visualization of the mucosa. However, there're some limitations, for instance, significant amounts of air are usually retained in the small bowel, which will lead to the distention and the pain of the gastrointestinal tract during and after the procedure.
Carbon dioxide(CO2), comparing to the air, is rapidly absorbed from the intestine, which allows the bowel to decompress more quickly and potentially decreases intraprocedural and postprocedural pain, sedation medication requirements, procedure time, and recovery time. It is also to the benefit of deeper intubation depth so that higher total enteroscopy rate and diagnostic rate will be achieved.
Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP and DBE examination, but it is still uncertain to the SBE procedure
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758900
|Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine|
|Shanghai, Shanghai, China, 200127|
|Principal Investigator:||Zhizheng Ge, Ph.D. MD.||Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine Shanghai|