Positioning of Surgical Patients With Sleep Apnea

September 14, 2015 updated by: Englewood Hospital and Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Englewood Hospital and Medical Center

Investigators

  • Principal Investigator: Aryeh Shander, MD, Englewood Hospital and Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 23, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-14-549

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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