An interventional study of Boussignac CPAP device and standard CPAP in Obstructive Sleep Apnea (OSA), sponsored by Queen's University. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-20.
Sponsored by Queen's University · Not applicable, Interventional, and Treatment
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 48 is close to the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
-> 18 years of age
Exclusion Criteria:
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
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
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.
Also known as: Boussignac CPAP device,
Standard of care postoperative treatment for OSA.
Also known as: standard of care CPAP
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
Time frame: 24 hours postoperatively
% forced expiratory volume in 1 second (FEV1)
Time frame: 1,2 and 24 hours post-operatively
Peak expiratory flow rate (PEFV)
Time frame: 1,2 and 24 hours postoperatively
This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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