Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02123238

Positioning of Surgical Patients With Sleep Apnea

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Englewood Hospital and Medical Center · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERbed positioning

Timeline

Start date
2014-04-01
Primary completion
2015-07-01
Completion
2015-12-01
First posted
2014-04-25
Last updated
2015-09-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02123238. Inclusion in this directory is not an endorsement.