Intubation Depth
Conditions
Keywords
Single-Balloon Enteroscopy
Brief summary
Small-balloon enteroscopy is a novel endoscopy system for examination of the deep small intestine.Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP(endoscopic retrograde cholangiopancreatography) and DBE(double-balloon enteroscopy) examination, but it is still uncertain to the SBE(single-balloon enteroscopy) procedure.
Detailed description
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
Interventions
DEVICECO2 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.
DEVICEAir insufflation
The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
Sponsors
Zhizheng Ge
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients referred for SBE at the trial centre
Exclusion criteria
* Age under 18 years, over 75 years Refusal of participation GIST(gastrointestinal stromal tumor), apparent tumor, post surgery Crohn's disease, Intestinal obstruction, stenosis, radiation enteritis Severe cardiopulmonary dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intubation Depth | Within 5 minutes after the examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Rate | Within 1 week after all the examinations are finished | — |
| Patient's Acceptability | 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. |
| Total Enteroscopy Rate | Within 1 week after all the examinations are finished | — |
| Abdominal Circumference | 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 | Within 1 week after all the examinations are finished | — |
| Procedure Time | Within 5 minutes after the examination | — |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CO2 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. | 106 |
| 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. | 108 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | difficulty for further intubation | 7 | 8 |
Baseline characteristics
| Characteristic | CO2 Insufflation Regulator | Air Insufflation Regulator | Total |
|---|---|---|---|
| Age, Continuous | 41.2 years STANDARD_DEVIATION 14.3 | 40.5 years STANDARD_DEVIATION 17.6 | 40.8 years STANDARD_DEVIATION 16 |
| Course of disease (month) | 13.1 months STANDARD_DEVIATION 20.2 | 13.9 months STANDARD_DEVIATION 22.1 | 13.5 months STANDARD_DEVIATION 21.1 |
| indications Abdominal distension | 7 participants | 5 participants | 12 participants |
| indications abdominal pain | 41 participants | 47 participants | 88 participants |
| indications Diarrhoea | 11 participants | 14 participants | 25 participants |
| indications Nausea | 2 participants | 0 participants | 2 participants |
| indications occult gastrointestinal bleeding | 41 participants | 38 participants | 79 participants |
| indications Vomiting | 2 participants | 2 participants | 4 participants |
| indications Weight loss | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 41 Participants | 48 Participants | 89 Participants |
| Sex: Female, Male Male | 65 Participants | 60 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 106 | 0 / 108 |
| serious Total, serious adverse events | 1 / 106 | 1 / 108 |
Outcome results
Primary
Intubation Depth
Time frame: Within 5 minutes after the examination
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CO2 Insufflation Regulator | Intubation Depth | 323.8 cm | Standard Deviation 64.2 |
| Air Insufflation Regulator | Intubation Depth | 238.3 cm | Standard Deviation 68.6 |
Secondary
Abdominal Circumference
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.
Time frame: 10 minutes before/after the examination
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CO2 Insufflation Regulator | Abdominal Circumference | After the procedure | 74.1 centimeter | Standard Deviation 9.7 |
| CO2 Insufflation Regulator | Abdominal Circumference | Before the procedure | 73.4 centimeter | Standard Deviation 9.6 |
| Air Insufflation Regulator | Abdominal Circumference | After the procedure | 73.6 centimeter | Standard Deviation 3.5 |
| Air Insufflation Regulator | Abdominal Circumference | Before the procedure | 70.3 centimeter | Standard Deviation 4.6 |
Secondary
Complication Rate
Time frame: Within 1 week after all the examinations are finished
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CO2 Insufflation Regulator | Complication Rate | 1 participants |
| Air Insufflation Regulator | Complication Rate | 1 participants |
Secondary
Diagnostic Rate
Time frame: Within 1 week after all the examinations are finished
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CO2 Insufflation Regulator | Diagnostic Rate | 58.5 Percentage of Participants |
| Air Insufflation Regulator | Diagnostic Rate | 47.2 Percentage of Participants |
Secondary
Patient's Acceptability
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.
Time frame: 6 hours after the examination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CO2 Insufflation Regulator | Patient's Acceptability | 105 participants |
| Air Insufflation Regulator | Patient's Acceptability | 107 participants |
Secondary
Procedure Time
Time frame: Within 5 minutes after the examination
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CO2 Insufflation Regulator | Procedure Time | Oral intubation | 77.9 minutes | Standard Deviation 36.3 |
| CO2 Insufflation Regulator | Procedure Time | Anal intubation | 86.4 minutes | Standard Deviation 43.7 |
| CO2 Insufflation Regulator | Procedure Time | Total enteroscopy examinations | 166.5 minutes | Standard Deviation 69.6 |
| Air Insufflation Regulator | Procedure Time | Oral intubation | 72.9 minutes | Standard Deviation 29.9 |
| Air Insufflation Regulator | Procedure Time | Anal intubation | 75.8 minutes | Standard Deviation 30.1 |
| Air Insufflation Regulator | Procedure Time | Total enteroscopy examinations | 155.1 minutes | Standard Deviation 57.1 |
Secondary
Total Enteroscopy Rate
Time frame: Within 1 week after all the examinations are finished
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CO2 Insufflation Regulator | Total Enteroscopy Rate | 37 participants |
| Air Insufflation Regulator | Total Enteroscopy Rate | 19 participants |