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
Results First Received: June 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Sleep Apnea, Obstructive
Delirium
Intervention: Device: CPAP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CPAP Patients in the continuous positive airway pressure (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.
Routine Care Routine care will be provided to the participant.

Participant Flow:   Overall Study
    CPAP     Routine Care  
STARTED     68     67  
COMPLETED     58     56  
NOT COMPLETED     10     11  
Lost to Follow-up                 7                 9  
Surgery Cancelled                 3                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
CPAP Patients in the continuous positive airway pressure (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.
Routine Care Routine care will be provided to the participant.
Total Total of all reporting groups

Baseline Measures
    CPAP     Routine Care     Total  
Number of Participants  
[units: participants]
  58     56     114  
Age  
[units: years]
Mean (Inter-Quartile Range)
  65   (60 to 70)     65   (59 to 71)     65   (60 to 71)  
Gender  
[units: participants]
     
Female     36     32     68  
Male     22     24     46  



  Outcome Measures
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1.  Primary:   Presence of Postoperative Delirium   [ Time Frame: Postoperative day 2 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew Krystal
Organization: Duke University
phone: (919) 668-1212
e-mail: andrew.krystal@dm.duke.edu


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