Post-extubation Boussignac CPAP System in Adults With Moderate to Severe Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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.

Official Title
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Use of the Boussignac CPAP System Immediately Following Extubation to Improve Lung Function in Adults With Moderate to Severe Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea (OSA)

Intervention / Treatment
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* Device: Boussignac CPAP device
* Device: standard CPAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boussignac CPAP device<br>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 | Device: Boussignac CPAP device<br>* 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.<br>* Other names: Boussignac CPAP device,;|
| Active Comparator: standard CPAP<br>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 | Device: standard CPAP<br>* Standard of care postoperative treatment for OSA.<br>* Other names: standard of care CPAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % forced expiratory volume in 1 second (FEV1) |  | 1,2 and 24 hours post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, CPAP, Boussignac