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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01249924
Enrollment
120
Registered
2010-11-30
Start date
2009-10-31
Completion date
2011-10-31
Last updated
2013-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia

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.

Interventions

DEVICEauto-titrated CPAP

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

DEVICEControl

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.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Apnea-hypopnea indexOn the third night after surgeryApnea-hypopnea index.

Secondary

MeasureTime frameDescription
Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90)2-3 nights before surgery and 5 nights after surgeryNocturnal oxygen desaturation index (ODI) and percentage of time with SaO2\<90%(CT90).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026