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

NCT01877928 | Terminated DMC

• 2 other identifiers: SMED-079-126006956
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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)

Keywords

Obstructive sleep apnea, CPAP, Boussignac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• % forced expiratory volume in 1 second (FEV1)

  1,2 and 24 hours post-operatively

Other Outcomes (1)

• Peak expiratory flow rate (PEFV)

  1,2 and 24 hours postoperatively

Study Arms (2)

Boussignac CPAP device

EXPERIMENTAL

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

standard CPAP

ACTIVE COMPARATOR

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

Interventions

Boussignac CPAP device 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.

Also known as: Boussignac CPAP device,

Boussignac CPAP device

standard CPAP DEVICE

Standard of care postoperative treatment for OSA.

Also known as: standard of care CPAP

standard CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Microcephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kim E Turner, MD, FRCPC

  Queen's University & Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 14, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

CA (1)