- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01816685
Effect of CPAP on Postoperative Delirium
August 4, 2015 updated by: Duke University
The Effect of Peri-operative Continuous Positive Airway Pressure (CPAP) on Postoperative Delirium in a Population at High-risk for Obstructive Sleep Apnea (OSA)
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 Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27701
- Duke University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Routine Care
|
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Experimental: CPAP
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of Postoperative Delirium
Time Frame: Postoperative day 2
|
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.
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Postoperative day 2
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Presence of Postoperative Delirium
Time Frame: Postoperative day 2
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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
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Postoperative day 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Krystal, MD, Department of Psychiatry, Duke University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
March 20, 2013
First Submitted That Met QC Criteria
March 20, 2013
First Posted (Estimate)
March 22, 2013
Study Record Updates
Last Update Posted (Estimate)
August 31, 2015
Last Update Submitted That Met QC Criteria
August 4, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Delirium
Other Study ID Numbers
- Pro00041457
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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