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

Study Overview
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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.

Official Title
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The Effectiveness of Perioperative CPAP to Reduce the Occurrence of Sleep Apnea Related Adverse Events in Surgical Patients With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea (OSA)

Intervention / Treatment
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* Device: auto-titrated CPAP
* Device: Control


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CPAP Group<br>CPAP Treatment | Device: auto-titrated CPAP<br>* Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.<br>|
| Other: Control Group<br>Routine care | Device: auto-titrated CPAP<br>* Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.<br>Device: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea index | Apnea-hypopnea index. | On the third night after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90) | Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90). | 2-3 nights before surgery and 5 nights after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia