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

NCT ID: NCT01877928

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-07-31

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.

Conditions

Obstructive Sleep Apnea (OSA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Boussignac CPAP device

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

standard CPAP

Intervention Type: DEVICE

Standard of care postoperative treatment for OSA.

Interventions

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.

Intervention Type: DEVICE

standard CPAP

Standard of care postoperative treatment for OSA.

Intervention Type: DEVICE

Other Intervention Names

Boussignac CPAP device,; standard of care CPAP

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kim Turner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kim E Turner, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University & Kingston General Hospital

Locations

Kingston General Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

6006956

Identifier Type: OTHER

Identifier Source: secondary_id

SMED-079-12

Identifier Type: -

Identifier Source: org_study_id