Effect of CPAP on Postoperative Delirium

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01816685
First received: March 20, 2013
Last updated: April 2, 2014
Last verified: April 2014
  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 will be made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool.


Secondary Outcome Measures:
  • Length of stay [ Time Frame: Discharge after surgery ] [ Designated as safety issue: No ]
  • ICU admission [ Time Frame: Prior to discharge after surgery ] [ Designated as safety issue: No ]
  • Hypoxia [ Time Frame: Prior to discharge after surgery ] [ Designated as safety issue: No ]
    Documented SpO2 < 90%

  • Reintubation [ Time Frame: Prior to discharge after surgery ] [ Designated as safety issue: No ]
  • Myocardial infarction/ischemia [ Time Frame: Prior to discharge after surgery ] [ Designated as safety issue: No ]
  • Wound infection [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: No ]
  • DVT/PE [ Time Frame: Prior to discharge after surgery ] [ Designated as safety issue: No ]
  • UTI [ Time Frame: Prior to discharge after surgery ] [ Designated as safety issue: No ]
  • Sepsis [ Time Frame: Prior to discharge after surgery ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: Prior to discharge after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated 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

  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 Recruiting
Durham, North Carolina, United States, 27701
Contact: Jacob W Nadler, MD, PhD       jacob.nadler@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Andrew Krystal, MD Department of Psychiatry, Duke University Medical Center
Study Chair: Jacob W Nadler, MD, PhD Department of Anesthesiology, 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
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014