Positioning of Surgical Patients With Sleep Apnea

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: bed positioning

• Registration Number: NCT02123238
• Lead Sponsor: Englewood Hospital and Medical Center

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-25
• Primary Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	bed positioning	standard of care positioning (0 degree)
30 degree	bed positioning	30 degree bed positioning
60 degree	bed positioning	60 degree bed positioning

Primary Outcome Measures

Name	Time	Method
Acute Hypoxic Index (AHI)	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

Trial Locations

Locations (1)

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, United States