Study Stopped
no funding
Positioning of Surgical Patients With Sleep Apnea
Non-Supine Positioning in Treatment of Surgical Patients With Obstructive Sleep Apnea
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 23, 2014
CompletedFirst Posted
Study publicly available on registry
April 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 15, 2015
September 1, 2015
1.2 years
April 23, 2014
September 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Control
OTHERstandard of care positioning (0 degree)
30 degree
OTHER30 degree bed positioning
60 degree
OTHER60 degree bed positioning
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aryeh Shander, MD
Englewood Hospital and Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2014
First Posted
April 25, 2014
Study Start
April 1, 2014
Primary Completion
July 1, 2015
Study Completion
December 1, 2015
Last Updated
September 15, 2015
Record last verified: 2015-09