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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: Boussignac CPAP device; Device: standard CPAP

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.; Other Names: Boussignac CPAP device,
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	Device: standard CPAP; Standard of care postoperative treatment for OSA.; Other Names: standard of care CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours postoperatively

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Peak expiratory flow rate (PEFV)	1,2 and 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Queen's University
• Investigators: Principal Investigator: Kim E Turner, MD, FRCPC, Queen's University & Kingston General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 12, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (Estimate): June 14, 2013

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea, CPAP, Boussignac
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: SMED-079-12; 6006956 (Other Identifier: Institutional Research Ethics board database)