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

NCT ID: NCT01249924

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea (OSA)

Keywords

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Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP Group

CPAP Treatment

Group Type OTHER

auto-titrated CPAP

Intervention Type DEVICE

Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.

Control Group

Routine care

Group Type OTHER

auto-titrated CPAP

Intervention Type DEVICE

Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.

Control

Intervention Type DEVICE

Patients in this group will receive routine care, undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for oxygen saturation level for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.

Interventions

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auto-titrated CPAP

Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.

Intervention Type DEVICE

Control

Patients in this group will receive routine care, undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for oxygen saturation level for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Dr. Frances Chung

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frances Chung, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto Western Hospital, Department of Aneshtesia

Toronto, Ontario, Canada

Site Status

Mount Sinai Hospital, Department of Anesthesia

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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0000

Identifier Type: -

Identifier Source: org_study_id