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Effect of CPAP on Postoperative Delirium

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ClinicalTrials.gov Identifier: NCT01816685
Recruitment Status : Completed
First Posted : March 22, 2013
Results First Posted : August 31, 2015
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Delirium Device: CPAP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Study Start Date : June 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
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.
 Device: CPAP
No Intervention: Routine Care


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Presence of Postoperative Delirium [ Time Frame: Postoperative day 2 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816685


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Andrew Krystal, MD Department of Psychiatry, Duke University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01816685    
Other Study ID Numbers: Pro00041457
First Posted: March 22, 2013    Key Record Dates
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Delirium
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Neurocognitive Disorders
Mental Disorders