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Clinical Trials/NCT02123238
NCT02123238
Withdrawn
Not Applicable

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

Englewood Hospital and Medical Center1 site in 1 countryApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Englewood Hospital and Medical Center
Locations
1
Primary Endpoint
Acute Hypoxic Index (AHI)
Status
Withdrawn
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Acute Hypoxic Index (AHI)

Time Frame: 3 days

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

Study Sites (1)

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