Trial Outcomes & Findings for Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27) (NCT NCT01316575)
NCT ID: NCT01316575
Last Updated: 2018-06-04
Results Overview
The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
1 hour following admission to PACU
Results posted on
2018-06-04
Participant Flow
Recruitment began 4 April 2011 and ended 29 April 2012. The target enrollment was 40. 40 patients were enrolled in the study.
Participant milestones
| Measure |
nCPAP
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
|
Low Flow Oxygen
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
nCPAP
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
|
Low Flow Oxygen
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Required alternate treatment
|
0
|
1
|
Baseline Characteristics
Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27)
Baseline characteristics by cohort
| Measure |
nCPAP
n=20 Participants
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
|
Low Flow Oxygen
n=20 Participants
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 12 • n=99 Participants
|
61 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
62 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hour following admission to PACUPopulation: From the literature, a sample size of 19 subjects per group is required for a power \>0.9 and alpha \<0.05 assuming a normalised difference in A-a gradient between groups of 0.33 and a Standard Deviation (SD) of 0.33
The alveolar - arterial gradient is the difference between the partial pressure of alveolar oxygen and the partial pressure of arterial oxygen
Outcome measures
| Measure |
nCPAP
n=18 Participants
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
|
Low Flow Oxygen
n=19 Participants
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
|
|---|---|---|
|
Alveolar - Arterial Gradient
|
70.6 torr
Standard Deviation 28.3
|
134 torr
Standard Deviation 72.6
|
SECONDARY outcome
Timeframe: Up to 2 weeksOutcome measures
| Measure |
nCPAP
n=18 Participants
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
|
Low Flow Oxygen
n=19 Participants
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
|
|---|---|---|
|
Number of Participants Requiring Reintubation
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 2 weeksOutcome measures
| Measure |
nCPAP
n=18 Participants
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
|
Low Flow Oxygen
n=19 Participants
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
|
|---|---|---|
|
Number of Participants Requiring Admission to ICU
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 2 weeksOutcome measures
| Measure |
nCPAP
n=18 Participants
The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
|
Low Flow Oxygen
n=19 Participants
The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
|
|---|---|---|
|
Length of Stay in Hospital
|
10 days
Standard Deviation 7.4
|
10.9 days
Standard Deviation 6.7
|
Adverse Events
nCPAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Flow Oxygen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place