Trials / Withdrawn
WithdrawnNCT02123238
Positioning of Surgical Patients With Sleep Apnea
Non-Supine Positioning in Treatment of Surgical Patients With Obstructive Sleep Apnea
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Englewood Hospital and Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The study aims to evaluate the effect of non-supine positioning in the treatment of surgical patients with obstructive sleep apnea. The hypothesis is that non-supine positioning will result in a decrease in acute hypoxic events, defined as the number of apneas/hypopneas per hour of sleep.
Detailed description
This is a prospective, randomized controlled trial that will comprise of two stages. Stage 1 is a pilot study of 30 patients at high risk or diagnosed with obstructive sleep apnea who are scheduled for routine surgery. These patients will be randomized 1:1:1 to standard of care (0 degree bed angle), 30 degree bed angle, or 60 degree bed angle. Acute hypoxic events will be analyzed pre and post-op in the randomly assigned bed position. PACU nurses will also be surveyed for patient-favored non-supine positioning (30 vs. 60 degrees). Stage 2 will be a larger, powered trial to evaluate the efficacy of just one bed angle (30 or 60 degrees) based on the Stage 1 results.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | bed positioning |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2015-07-01
- Completion
- 2015-12-01
- First posted
- 2014-04-25
- Last updated
- 2015-09-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02123238. Inclusion in this directory is not an endorsement.