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

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249924
• Other study ID #: 0000
• Status: Completed
• Phase: N/A
• First received: November 26, 2010
• Last updated: December 17, 2013
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: July 2012
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital, Department of Anesthesia	Toronto	Ontario
Canada	Toronto Western Hospital, Department of Aneshtesia	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index	Apnea-hypopnea index.	On the third night after surgery	Yes
Secondary	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	Yes