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

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01877928
• Other study ID #: SMED-079-12
• Secondary ID: 6006956
• Status: Terminated
• Phase: N/A
• First received: June 12, 2013
• Last updated: March 16, 2018
• Start date: June 2013
• Est. completion date: July 2016

Study information

• Verified date: March 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• standard CPAP
Standard of care postoperative treatment for OSA.

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peak expiratory flow rate (PEFV)		1,2 and 24 hours postoperatively
Primary	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	% forced expiratory volume in 1 second (FEV1)		1,2 and 24 hours post-operatively