Back to resultsPost-extubation Boussignac CPAP System in Adults With Moderate to Severe Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea (OSA)
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Boussignac CPAP device
standard CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA) focused on measuring Obstructive sleep apnea, CPAP, Boussignac
Eligibility Criteria
Inclusion Criteria:
-> 18 years of age
- ASA II-IV
- Previous diagnosis of moderate to severe obstructive sleep apnea
- diagnosed via polysomnography
- BMI < 40
- scheduled for an abdominal or peripheral surgical procedure requiring endotracheal intubation and admission to hospital
Exclusion Criteria:
- BMI > 40
- Age <18 years
- inability to provide signed informed consent
- intra-thoracic
- head or neck surgery
- contraindication for immediate post-extubation application of CPAP
- not expected to be eligible for timely extubation following the surgical procedure
Sites / Locations
- Kingston General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Boussignac CPAP device
standard CPAP
Arm Description
Patients previously diagnosed with obstructive sleep apnea and who are undergoing abdominal or peripheral surgery will have the Boussignac CPAP mask applied for 1 hour starting immediately post-extubation
Patients previously diagnosed with obstructive sleep apnea who are undergoing peripheral or abdominal surgical procedures will receive the standard-of-care for obstructive sleep apnea. This typically involves CPAP application only at night
Outcomes
Primary Outcome Measures
percent forced vital capacity %(FVC)
%FVC will be assessed 24 hours postoperatively in patients who received the Boussignac CPAP mask immediately post-extubation and these values compared to those of patients who received the standard-of-care treatment for obstructive sleep apnea
Secondary Outcome Measures
% forced expiratory volume in 1 second (FEV1)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01877928
Brief Title
Post-extubation Boussignac CPAP System in Adults With Moderate to Severe Obstructive Sleep Apnea
Official Title
Use of the Boussignac CPAP System Immediately Following Extubation to Improve Lung Function in Adults With Moderate to Severe Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Most OSA patients were not obese and/or admitted over night so the study was not feasible.
Study Start Date
June 2013 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of the Boussignac positive airway pressure system (a mask) applied immediately following post-operative extubation in improving lung function in patients with obstructive sleep apnea (OSA). Assessments will be done before surgery and then at 1, 2 and 24 hours following extubation and will be compared to standard care for perioperative airway support. The study aims to give a broader and more inclusive picture (than the current literature) in terms of whether the Boussignac CPAP system should be considered for utilization by anesthesiologists caring for surgical patients with OSA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
Keywords
Obstructive sleep apnea, CPAP, Boussignac
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Boussignac CPAP device
Arm Type
Experimental
Arm Description
Patients previously diagnosed with obstructive sleep apnea and who are undergoing abdominal or peripheral surgery will have the Boussignac CPAP mask applied for 1 hour starting immediately post-extubation
Arm Title
standard CPAP
Arm Type
Active Comparator
Arm Description
Patients previously diagnosed with obstructive sleep apnea who are undergoing peripheral or abdominal surgical procedures will receive the standard-of-care for obstructive sleep apnea. This typically involves CPAP application only at night
Intervention Type
Device
Intervention Name(s)
Boussignac CPAP device
Other Intervention Name(s)
Boussignac CPAP device,
Intervention Description
Is a continuous positive airway pressure (CPAP) system marketed in Canada and the US for the treatment of Obstructive Sleep Apnea. The main difference is that this system is portable wheres the standard hospital CPAP is not. This allows for the application immediately post-extubation.
Intervention Type
Device
Intervention Name(s)
standard CPAP
Other Intervention Name(s)
standard of care CPAP
Intervention Description
Standard of care postoperative treatment for OSA.
Primary Outcome Measure Information:
Title
percent forced vital capacity %(FVC)
Description
%FVC will be assessed 24 hours postoperatively in patients who received the Boussignac CPAP mask immediately post-extubation and these values compared to those of patients who received the standard-of-care treatment for obstructive sleep apnea
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
% forced expiratory volume in 1 second (FEV1)
Time Frame
1,2 and 24 hours post-operatively
Other Pre-specified Outcome Measures:
Title
Peak expiratory flow rate (PEFV)
Time Frame
1,2 and 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-> 18 years of age
ASA II-IV
Previous diagnosis of moderate to severe obstructive sleep apnea
diagnosed via polysomnography
BMI < 40
scheduled for an abdominal or peripheral surgical procedure requiring endotracheal intubation and admission to hospital
Exclusion Criteria:
BMI > 40
Age <18 years
inability to provide signed informed consent
intra-thoracic
head or neck surgery
contraindication for immediate post-extubation application of CPAP
not expected to be eligible for timely extubation following the surgical procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim E Turner, MD, FRCPC
Organizational Affiliation
Queen's University & Kingston General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Post-extubation Boussignac CPAP System in Adults With Moderate to Severe Obstructive Sleep Apnea
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