Positioning of Surgical Patients With Sleep Apnea

NCT ID: NCT02123238

Last Updated: 2015-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

standard of care positioning (0 degree)

Group Type OTHER

bed positioning

Intervention Type OTHER

30 degree

30 degree bed positioning

Group Type OTHER

bed positioning

Intervention Type OTHER

60 degree

60 degree bed positioning

Group Type OTHER

bed positioning

Intervention Type OTHER

Interventions

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bed positioning

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Englewood Hospital and Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aryeh Shander, MD

Role: PRINCIPAL_INVESTIGATOR

Englewood Hospital and Medical Center

Locations

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Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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E-14-549

Identifier Type: -

Identifier Source: org_study_id

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