Prophylactic nCPAP Following Bowel Surgery (Bio-REB File 11-27)

This study has been completed.
Sponsor:
Collaborator:
Royal University Hospital Foundation
Information provided by (Responsible Party):
William McKay, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01316575
First received: March 7, 2011
Last updated: January 22, 2013
Last verified: January 2013
Results First Received: July 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Postoperative Pulmonary Atelectasis
Surgery
Interventions: Device: nCPAP
Device: Low Flow Oxygen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began 4 April 2011 and ended 29 April 2012. The target enrollment was 40. 40 patients were enrolled in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    nCPAP     Low Flow Oxygen  
STARTED     20     20  
COMPLETED     18     19  
NOT COMPLETED     2     1  
Withdrawal by Subject                 2                 0  
Required alternate treatment                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    nCPAP     Low Flow Oxygen     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 12     61  ± 11.4     62  ± 11.6  
Gender  
[units: participants]
     
Female     6     13     19  
Male     14     7     21  
Region of Enrollment  
[units: participants]
     
Canada     20     20     40  



  Outcome Measures
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1.  Primary:   Alveolar - Arterial Gradient   [ Time Frame: 1 hour following admission to PACU ]

2.  Secondary:   Number of Participants Requiring Reintubation   [ Time Frame: Up to 2 weeks ]

3.  Secondary:   Number of Participants Requiring Admission to ICU   [ Time Frame: Up to 2 weeks ]

4.  Secondary:   Length of Stay in Hospital   [ Time Frame: Up to 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

We made an assumption for FiO2, the respiratory quotient and barometric pressure in the alveolar air equation.

We did not standardize the time between extubation and application of nCPAP.



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