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

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ClinicalTrials.gov Identifier: NCT01249924
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Frances Chung, University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea (OSA) Device: auto-titrated CPAP Device: Control Not Applicable

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Apnea-hypopnea index [ Time Frame: On the third night after surgery ]
    Apnea-hypopnea index.


Secondary Outcome Measures :
  1. 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 ]
    Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Frances Chung, Anesthesiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01249924     History of Changes
Other Study ID Numbers: 0000
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: July 2012

Keywords provided by Dr. Frances Chung, 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 Wake Disorders
Nervous System Diseases