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

Queen's University

Status: Terminated

Conditions: Obstructive Sleep Apnea (OSA)

Treatments: Device: standard CPAP; Device: Boussignac CPAP device

Study type: Interventional

Funder types: Other

Identifiers

NCT01877928

SMED-079-12

6006956 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Boussignac CPAP device

Experimental group

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

Treatment:

Device: Boussignac CPAP device

standard CPAP

Active Comparator group

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

Treatment:

Device: standard CPAP