Positioning of Surgical Patients With Sleep Apnea

Study Overview
=================
Brief 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.

Official Title
-----------------
Non-Supine Positioning in Treatment of Surgical Patients With Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Other: bed positioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum 1 night postoperative hospital stay More than 18 and less than 80 years old Identified as high risk of OSA (SACS > 15) or a history of OSA without CPAP treatment Exclusion Criteria: Unwilling or unable to give informed consent Undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery Currently undergoing treatment for sleep apnea including CPAP Requiring prolonged postoperative ventilation NYHA functional class III and IV Valvular heart disease, dilated cardiomyopathy, implanted cardiac pacemaker, or unstable angina Myocardial infarction or cardiac surgery within 3 months Chronic obstructive pulmonary disease, or asthma Presence of tracheostomy, facial, neck, or chest wall abnormalities Abdominal aortic aneurysm surgery, chemotherapy, or immunosuppressive therapy within 3 months Visiting preoperative clinic less than 3 days before surgery Requiring postoperative nasogastric tube

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>standard of care positioning (0 degree) | Other: bed positioning<br> <br> |
| Other: 30 degree<br>30 degree bed positioning | Other: bed positioning<br> <br> |
| Other: 60 degree<br>60 degree bed positioning | Other: bed positioning<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Hypoxic Index (AHI) | study will look at the effect of bed positioning on Acute Hypoxic Index (AHI), which is defined as the number of apneas/hypopneas per hour of sleep | 3 days |