Trial Outcomes & Findings for CO2 Versus Air Insufflation for Single-balloon Enteroscopy (NCT NCT01758900)
NCT ID: NCT01758900
Last Updated: 2016-11-25
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
214 participants
Primary outcome timeframe
Within 5 minutes after the examination
Results posted on
2016-11-25
Participant Flow
Participant milestones
| Measure |
CO2(Carbon Dioxide) Insufflation Regulator
Device: CO2 insufflation regulator
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(single-balloon enteroscopy).
|
Air Insufflation Regulator
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
108
|
|
Overall Study
COMPLETED
|
99
|
100
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
CO2(Carbon Dioxide) Insufflation Regulator
Device: CO2 insufflation regulator
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(single-balloon enteroscopy).
|
Air Insufflation Regulator
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Overall Study
difficulty for further intubation
|
7
|
8
|
Baseline Characteristics
CO2 Versus Air Insufflation for Single-balloon Enteroscopy
Baseline characteristics by cohort
| Measure |
CO2 Insufflation Regulator
n=106 Participants
Device: CO2 insufflation regulator
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.
|
Air Insufflation Regulator
n=108 Participants
Room air will be used for insufflation as the Active Comparator arm
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.
|
Total
n=214 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 17.6 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Course of disease (month)
|
13.1 months
STANDARD_DEVIATION 20.2 • n=5 Participants
|
13.9 months
STANDARD_DEVIATION 22.1 • n=7 Participants
|
13.5 months
STANDARD_DEVIATION 21.1 • n=5 Participants
|
|
indications
abdominal pain
|
41 participants
n=5 Participants
|
47 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
indications
occult gastrointestinal bleeding
|
41 participants
n=5 Participants
|
38 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
indications
Diarrhoea
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
indications
Abdominal distension
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
indications
Weight loss
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
indications
Nausea
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
indications
Vomiting
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 5 minutes after the examinationOutcome measures
| Measure |
CO2 Insufflation Regulator
n=106 Participants
Device: CO2 insufflation regulator
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.
|
Air Insufflation Regulator
n=108 Participants
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Intubation Depth
|
323.8 cm
Standard Deviation 64.2
|
238.3 cm
Standard Deviation 68.6
|
SECONDARY outcome
Timeframe: Within 1 week after all the examinations are finishedOutcome measures
| Measure |
CO2 Insufflation Regulator
n=106 Participants
Device: CO2 insufflation regulator
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.
|
Air Insufflation Regulator
n=108 Participants
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Total Enteroscopy Rate
|
37 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Within 1 week after all the examinations are finishedOutcome measures
| Measure |
CO2 Insufflation Regulator
n=106 Participants
Device: CO2 insufflation regulator
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.
|
Air Insufflation Regulator
n=108 Participants
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Diagnostic Rate
|
58.5 Percentage of Participants
|
47.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: 6 hours after the examinationAcceptability 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.
Outcome measures
| Measure |
CO2 Insufflation Regulator
n=106 Participants
Device: CO2 insufflation regulator
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.
|
Air Insufflation Regulator
n=108 Participants
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Patient's Acceptability
|
105 participants
|
107 participants
|
SECONDARY outcome
Timeframe: Within 5 minutes after the examinationOutcome measures
| Measure |
CO2 Insufflation Regulator
n=106 Participants
Device: CO2 insufflation regulator
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.
|
Air Insufflation Regulator
n=108 Participants
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Procedure Time
Oral intubation
|
77.9 minutes
Standard Deviation 36.3
|
72.9 minutes
Standard Deviation 29.9
|
|
Procedure Time
Anal intubation
|
86.4 minutes
Standard Deviation 43.7
|
75.8 minutes
Standard Deviation 30.1
|
|
Procedure Time
Total enteroscopy examinations
|
166.5 minutes
Standard Deviation 69.6
|
155.1 minutes
Standard Deviation 57.1
|
SECONDARY outcome
Timeframe: 10 minutes before/after the examinationTo 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.
Outcome measures
| Measure |
CO2 Insufflation Regulator
n=99 Participants
Device: CO2 insufflation regulator
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.
|
Air Insufflation Regulator
n=100 Participants
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Abdominal Circumference
Before the procedure
|
73.4 centimeter
Standard Deviation 9.6
|
70.3 centimeter
Standard Deviation 4.6
|
|
Abdominal Circumference
After the procedure
|
74.1 centimeter
Standard Deviation 9.7
|
73.6 centimeter
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Within 1 week after all the examinations are finishedOutcome measures
| Measure |
CO2 Insufflation Regulator
n=106 Participants
Device: CO2 insufflation regulator
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.
|
Air Insufflation Regulator
n=108 Participants
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Complication Rate
|
1 participants
|
1 participants
|
Adverse Events
CO2 Insufflation Regulator
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Air Insufflation Regulator
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CO2 Insufflation Regulator
n=106 participants at risk
Device: CO2 insufflation regulator
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.
|
Air Insufflation Regulator
n=108 participants at risk
Room air will be used for insufflation as the Active Comparator arm
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.
|
|---|---|---|
|
Gastrointestinal disorders
acute haemorrhage
|
0.94%
1/106 • Number of events 1 • Adverse event was defined as any event that changed the health status of a patient, occurring within 30 days after enteroscopy examination.
|
0.00%
0/108 • Adverse event was defined as any event that changed the health status of a patient, occurring within 30 days after enteroscopy examination.
|
|
Gastrointestinal disorders
acute pancreatitis
|
0.00%
0/106 • Adverse event was defined as any event that changed the health status of a patient, occurring within 30 days after enteroscopy examination.
|
0.93%
1/108 • Number of events 1 • Adverse event was defined as any event that changed the health status of a patient, occurring within 30 days after enteroscopy examination.
|
Other adverse events
Adverse event data not reported
Additional Information
Zhizheng Ge, MD. Ph.D. Director of the Clinical Trials
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Phone: 86-21-68383015
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place