Trials / Completed
CompletedNCT01249924
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2011-10-01
- Completion
- 2011-10-01
- First posted
- 2010-11-30
- Last updated
- 2013-12-18
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT01249924. Inclusion in this directory is not an endorsement.