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

March 20, 2013
August 4, 2015
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 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
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
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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.

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.

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.
 
Completed
135
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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01816685
Pro00041457
Not Provided
Duke University
Duke University
Not Provided
Principal Investigator: Andrew Krystal, MD Department of Psychiatry, Duke University Medical Center
Duke University
August 2015

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