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

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea (OSA)
• Interventions: Device: Boussignac CPAP device; Device: standard CPAP

• Registration Number: NCT01877928
• Lead Sponsor: Queen's University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-14
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boussignac CPAP device	Boussignac CPAP device	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
standard CPAP	standard CPAP	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
% forced expiratory volume in 1 second (FEV1)	1,2 and 24 hours post-operatively

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada