Positioning of Surgical Patients With Sleep Apnea

Englewood Hospital and Medical Center

Status: Withdrawn

Conditions: Obstructive Sleep Apnea

Treatments: Other: bed positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02123238

E-14-549

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

Control

Other group

Description:

standard of care positioning (0 degree)

Treatment:

Other: bed positioning

30 degree

Other group

Description:

30 degree bed positioning

Treatment:

Other: bed positioning

60 degree

Other group

Description:

60 degree bed positioning

Treatment:

Other: bed positioning