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

March 20, 2013
April 2, 2014
June 2013
June 2014   (final data collection date for primary outcome measure)
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.
Presence of postoperative delirium [ Time Frame: Postoperative day 2 ]
Assessments for delirium will be made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool.
Complete list of historical versions of study NCT01816685 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Effect of CPAP on Postoperative Delirium
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Sleep Apnea, Obstructive
  • Delirium
Device: CPAP
  • 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.
    Intervention: Device: CPAP
  • No Intervention: Routine Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
United States
 
NCT01816685
Pro00041457
Not Provided
Duke University
Duke University
Not Provided
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
Duke University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP