Clinical trial NCT01249924: The Effectiveness of Perioperative CPAP to Reduce Obstructive Sleep Apnea Related Adverse Events
Official title: The Effectiveness of Perioperative CPAP to Reduce the Occurrence of Sleep Apnea Related Adverse Events in Surgical Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Apnea-hypopnea index
timeFrame: On the third night after surgery
Secondary outcomes:
measure: Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90)
timeFrame: 2-3 nights before surgery and 5 nights after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital, Department of Aneshtesia
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital, Department of Anesthesia
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Frances Chung, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: