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

University Health Network, Toronto

Status: Completed

Conditions: Obstructive Sleep Apnea (OSA)

Treatments: Device: Control; Device: auto-titrated CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01249924

0000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

CPAP Group

Other group

Description:

CPAP Treatment

Treatment:

Device: auto-titrated CPAP

Control Group

Other group

Description:

Routine care

Treatment:

Device: auto-titrated CPAP

Device: Control