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Positioning of Surgical Patients With Sleep Apnea

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02123238
Enrollment
0
Registered
2014-04-25
Start date
2014-04-30
Completion date
2015-12-31
Last updated
2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

OTHERbed positioning

Sponsors

Englewood Hospital and Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Acute Hypoxic Index (AHI)3 daysstudy 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026