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Effect of CPAP on Postoperative Delirium

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01816685
First Posted: March 22, 2013
Last Update Posted: August 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
Results First Submitted: June 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01816685     History of Changes
Other Study ID Numbers: Pro00041457
First Submitted: March 20, 2013
First Posted: March 22, 2013
Results First Submitted: June 28, 2015
Results First Posted: August 31, 2015
Last Update Posted: August 31, 2015