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Combining Objective and Subjective Sedation Assessment Tools (COST_2)

This study has been completed.
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00734409
First received: June 3, 2008
Last updated: March 21, 2013
Last verified: August 2012
Results First Received: August 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Critical Illness
Intervention: Device: Bispectral Index (BIS) Monitor

  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
Patients were in the Medical ICU or Neuro ICU at Duke University Hospital or the mixed ICU at Durham Regional. If patients met all inclusion criteria and no exclusion criteria, the attending was asked if patient's legally authorized representative (LAR) could be approached for consent. Enrollment started May of 2008 and closed April of 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were only excluded from the trial after consent and prior to randomization if they no longer met inclusion criteria, for instance the medical team decided to remove sedatives.

Reporting Groups
  Description
RASS Plus BIS Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
RASS Only Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution

Participant Flow:   Overall Study
    RASS Plus BIS   RASS Only
STARTED   155   145 
COMPLETED   155   145 
NOT COMPLETED   0   0 



  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
RASS Plus BIS Participants in this arm will receive sedation assessment with the RASS scale augmented with BIS monitoring.
RASS Only Participants will receive sedation assessment only using the RASS scale which is the standard of care at our institution
Total Total of all reporting groups

Baseline Measures
   RASS Plus BIS   RASS Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 155   145   300 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   102   99   201 
>=65 years   53   46   99 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.95  (18.15)   57.7  (15.30)   55.78  (16.91) 
Gender 
[Units: Participants]
     
Female   76   71   147 
Male   79   74   153 
Region of Enrollment 
[Units: Participants]
     
United States   155   145   300 


  Outcome Measures
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1.  Primary:   Mean Sedative Use   [ Time Frame: Intensive Care Unit (ICU) stay through discharge ]

2.  Secondary:   Unplanned Self-device Removal Events   [ Time Frame: ICU stay through discharge ]

3.  Secondary:   Mean Days on Mechanical Ventilation   [ Time Frame: ICU stay- through discharge ]


  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: DaiWai M Olson, PhD RN
Organization: Duke University Health System
phone: (919) 668-3751
e-mail: Olson006@mc.duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734409     History of Changes
Other Study ID Numbers: PRO00002117
DUHS parent 3930938 ( Other Grant/Funding Number: Covidien )
Study First Received: June 3, 2008
Results First Received: August 10, 2012
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board