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Completed

NCT Number: NCT01249924

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Department of Anesthesia, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

auto-titrated CPAP

Device

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

Control

Device

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 outcomes

  1. Apnea-hypopnea index

    Time frame: On the third night after surgery

    Apnea-hypopnea index.

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 30, 2010
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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