Positioning of Surgical Patients With Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02123238
• Other study ID #: E-14-549
• Status: Withdrawn
• Phase: N/A
• First received: April 23, 2014
• Last updated: September 14, 2015
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Englewood Hospital and Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• bed positioning

Locations

Country	Name	City	State
United States	Englewood Hospital and Medical Center	Englewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Englewood Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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