Back to resultsPositioning of Surgical Patients With Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bed positioning
Sponsored by
About this trial
This is an interventional prevention trial for Obstructive Sleep Apnea
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
Sites / Locations
- Englewood Hospital and Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Control
30 degree
60 degree
Arm Description
standard of care positioning (0 degree)
30 degree bed positioning
60 degree bed positioning
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02123238
First Posted
April 23, 2014
Last Updated
September 14, 2015
Sponsor
Englewood Hospital and Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02123238
Brief Title
Positioning of Surgical Patients With Sleep Apnea
Official Title
Non-Supine Positioning in Treatment of Surgical Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
no funding
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Englewood Hospital and Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
standard of care positioning (0 degree)
Arm Title
30 degree
Arm Type
Other
Arm Description
30 degree bed positioning
Arm Title
60 degree
Arm Type
Other
Arm Description
60 degree bed positioning
Intervention Type
Other
Intervention Name(s)
bed positioning
Primary Outcome Measure Information:
Title
Acute Hypoxic Index (AHI)
Description
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
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aryeh Shander, MD
Organizational Affiliation
Englewood Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Positioning of Surgical Patients With Sleep Apnea
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