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

Overview

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.

Full Title of Study: “Use of the Boussignac CPAP System Immediately Following Extubation to Improve Lung Function in Adults With Moderate to Severe Obstructive Sleep Apnea”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 2016

Interventions

  • Device: Boussignac 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.
  • Device: standard CPAP
    • Standard of care postoperative treatment for OSA.

Arms, Groups and Cohorts

  • Experimental: 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
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • percent forced vital capacity %(FVC)
    • Time Frame: 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 Measures

  • % forced expiratory volume in 1 second (FEV1)
    • Time Frame: 1,2 and 24 hours post-operatively

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Queen’s University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Kim Turner, Principal Investigator – Queen’s University
  • Overall Official(s)
    • Kim E Turner, MD, FRCPC, Principal Investigator, Queen’s University & Kingston General Hospital

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