Effect of CPAP on Postoperative Delirium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01816685
First received: March 20, 2013
Last updated: August 4, 2015
Last verified: August 2015
  Purpose

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 Intervention
Sleep Apnea, Obstructive
Delirium
Device: CPAP

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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


Enrollment: 135
Study Start Date: June 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816685

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Andrew Krystal, MD Department of Psychiatry, Duke University Medical Center
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01816685     History of Changes
Other Study ID Numbers: Pro00041457
Study First Received: March 20, 2013
Results First Received: June 28, 2015
Last Updated: August 4, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Delirium
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on September 03, 2015