Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Obstructive sleep apnea, CPAP, Boussignac
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.
Interventions
DEVICEBoussignac CPAP device
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.
DEVICEstandard CPAP
Standard of care postoperative treatment for OSA.
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percent forced vital capacity %(FVC) | 24 hours postoperatively | %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
| Measure | Time frame |
|---|---|
| % forced expiratory volume in 1 second (FEV1) | 1,2 and 24 hours post-operatively |
Other
| Measure | Time frame |
|---|---|
| Peak expiratory flow rate (PEFV) | 1,2 and 24 hours postoperatively |
Countries
Canada
Outcome results
None listed