Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01249924
First received: November 26, 2010
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea (OSA)
 Device: auto-titrated CPAP
Device: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of Perioperative CPAP to Reduce the Occurrence of Sleep Apnea Related Adverse Events in Surgical Patients With Obstructive Sleep Apnea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Apnea-hypopnea index [ Time Frame: On the third night after surgery ] [ Designated as safety issue: Yes ]
    Apnea-hypopnea index.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90).


Enrollment: 120
Study Start Date: October 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249924

Locations
Canada, Ontario
Toronto Western Hospital, Department of Aneshtesia
Toronto, Ontario, Canada, M5T2S8
Mount Sinai Hospital, Department of Anesthesia
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Frances Chung, FRCPC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01249924     History of Changes
Other Study ID Numbers: 0000
Study First Received: November 26, 2010
Last Updated: July 20, 2012
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013