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

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
auto-titrated CPAP
Control
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea (OSA) focused on measuring Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toronto Western Hospital, Department of Aneshtesia
  • Mount Sinai Hospital, Department of Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CPAP Group

Control Group

Arm Description

CPAP Treatment

Routine care

Outcomes

Primary Outcome Measures

Apnea-hypopnea index
Apnea-hypopnea index.

Secondary Outcome Measures

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).

Full Information

First Posted
November 26, 2010
Last Updated
December 17, 2013
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01249924
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)
Keywords
Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP Group
Arm Type
Other
Arm Description
CPAP Treatment
Arm Title
Control Group
Arm Type
Other
Arm Description
Routine care
Intervention Type
Device
Intervention Name(s)
auto-titrated CPAP
Intervention Description
Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Apnea-hypopnea index
Description
Apnea-hypopnea index.
Time Frame
On the third night after surgery
Secondary Outcome Measure Information:
Title
Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90)
Description
Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90).
Time Frame
2-3 nights before surgery and 5 nights after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances Chung, FRCPC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital, Department of Aneshtesia
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Facility Name
Mount Sinai Hospital, Department of Anesthesia
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

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

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