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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Device: auto-titrated CPAP; Device: Control

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T2S8
      • Toronto Western Hospital, Department of Aneshtesia
    • Toronto, Ontario, Canada
      • Mount Sinai Hospital, Department of Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Frances Chung, FRCPC, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 26, 2010
• First Submitted That Met QC Criteria: November 26, 2010
• First Posted (Estimate): November 30, 2010

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 17, 2013
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 0000 (Centre for care Science, KI, Norrbacka Eugeniastiftelsen)