Effect of CPAP on Postoperative Delirium
Patients with a medical condition known as obstructive sleep apnea may be at increased risk of delirium following surgery. This study loans autotitrating CPAP machines to randomly-selected patients who are at high-risk for obstructive sleep apnea with the goal of preventing post-operative delirium.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||The Effect of Peri-operative Continuous Positive Airway Pressure (CPAP) on Postoperative Delirium in a Population at High-risk for Obstructive Sleep Apnea (OSA)|
- Presence of Postoperative Delirium [ Time Frame: Postoperative day 2 ] [ Designated as safety issue: No ]Assessments for delirium were made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool. The DRS-R-98 is a 16-item clinician-rated scale that consists of a severity score (maximum score 39, minimum 0) made up of items that can be used for repeated serial measurements and a total scale score (maximum score 46, minimum 0) that includes the severity score plus three diagnostic items (7 additional possible points) used for initial ratings. Items represent symptoms that are rated on a scale of 0 to 3 points, with text descriptions for each point. Higher scores on the scale represents a larger number of delirium symptoms or increased severity of those symptoms.
- Presence of Postoperative Delirium [ Time Frame: Postoperative day 2 ] [ Designated as safety issue: No ]Assessments for delirium were made on postoperative day 2 using the Confusion Assessment Method (CAM) Diagnostic Algorithm. This binary tool identifies the presence or absence of delirium
|Study Start Date:||June 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
|No Intervention: Routine Care|
Patients undergoing elective knee and hip replacements will be prospectively enrolled. These surgical procedures all have an expected length of stay > 3 days. Immediately following enrollment, patients will be randomized to receive CPAP or routine peri-operative care. Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01816685
|United States, North Carolina|
|Durham, North Carolina, United States, 27701|
|Principal Investigator:||Andrew Krystal, MD||Department of Psychiatry, Duke University Medical Center|