Effect of CPAP on Postoperative Delirium

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Peri-operative Continuous Positive Airway Pressure (CPAP) on Postoperative Delirium in a Population at High-risk for Obstructive Sleep Apnea (OSA)

Conditions
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Sleep Apnea, Obstructive, Delirium

Intervention / Treatment
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* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 and above Scheduled for an elective knee or hip replacement Ability to speak English and give informed consent At risk for obstructive sleep apnea as defined by a STOP-BANG score > 2 Exclusion Criteria: History of psychiatric or neurologic illness that would confound delirium assessment Severe tracheal or lung disease Contraindications to face-mask CPAP Treated OSA

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP<br>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. | Device: CPAP<br> <br> |
| No Intervention: Routine Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Postoperative Delirium | 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. | Postoperative day 2 | 
| Presence of Postoperative Delirium | 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 | Postoperative day 2 |