The Effectiveness of Perioperative CPAP to Reduce Obstructive Sleep Apnea Related Adverse Events

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea (OSA)
• Interventions: Device: auto-titrated CPAP; Device: Control

• Registration Number: NCT01249924
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients with moderate and severe OSA.

Detailed Description

The patients will be approached by the study coordinators at the preoperative clinic. If the patient is interested in participating the study, STOP-Bang and Epworth questionnaires will be implemented to determine the risk for OSA.If the patients are classified as high risk of having OSA, they are scheduled for an overnight sleep study at home. The patients with Apnea-Hypopnea Index (AHI)\>15 from the sleep study will be randomized into two study groups: Perioperative CPAP group or control group (routine care). In the perioperative CPAP group, patients will be treated with auto-CPAP for 2-3 nights preoperatively and 5 nights postoperatively. All patients will undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for 2-3 nights preoperatively and 5 nights postoperatively.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-11-26
• Study First Submitted QC: 2010-11-26
• Study First Posted: 2010-11-30
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-07
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

the patients who meet the following criteria will be recruited

• Patients who are scheduled for inpatient surgery that required a minimum of three nights of hospital stay
• Age: >18 and <80 years old.
• Identified as high risk of having OSA or diagnosed with OSA without using CPAP.

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Exclusion Criteria

• Undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery.
• Unwilling or unable to give informed consent.
• Currently undergoing treatment for sleep apnea including CPAP.
• Requiring prolonged postoperative ventilation.
• New York Heart Association functional class III and IV.
• Having valvular heart disease, dilated cardiomyopathy, implanted cardiac pacemaker, or unstable angina.
• Having myocardial infarction or cardiac surgery within 3 months.
• Having chronic obstructive pulmonary disease, or asthma.
• Having a presence of tracheostomy, facial, neck, or chest wall abnormalities.
• Having abdominal aortic aneurysm surgery, chemotherapy, or immunosuppressive therapy within 3 months.
• Visiting preoperative clinic less than 3 days before scheduled surgery date.
• On nasogastric tube postoperatively.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP Group	auto-titrated CPAP	CPAP Treatment
Control Group	auto-titrated CPAP	Routine care
Control Group	Control	Routine care

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index	On the third night after surgery	Apnea-hypopnea index.

Secondary Outcome Measures

Name	Time	Method
Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90)	2-3 nights before surgery and 5 nights after surgery	Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2\<90%(CT90).

Trial Locations

Locations (2)

Toronto Western Hospital, Department of Aneshtesia; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital, Department of Anesthesia; 🇨🇦 Toronto, Ontario, Canada