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Clinical Trials/NCT01877928
NCT01877928
Terminated
Not Applicable

Use of the Boussignac CPAP System Immediately Following Extubation to Improve Lung Function in Adults With Moderate to Severe Obstructive Sleep Apnea

Queen's University1 site in 1 country48 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea (OSA)
Sponsor
Queen's University
Enrollment
48
Locations
1
Primary Endpoint
percent forced vital capacity %(FVC)
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
July 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Kim Turner

Principal Investigator

Queen's University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

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

Study Sites (1)

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