Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation

This study has been terminated.
(Slow recruitment of subjects)
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00606554
First received: January 3, 2008
Last updated: July 24, 2013
Last verified: June 2011
Results First Received: February 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Respiratory Insufficiency
Interventions: Device: Computer-driven weaning program - Drager Evita Smartcare System
Behavioral: Standard of Care weaning

  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
Recruitment start 1/2008 recruitment end: 5/2010 Recruited from Medical Intensive Care Unites Boston medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Computer-assisted Wean Group assigned to the computer-assisted weaning program Intervention Group
Standard of Care

Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.

Comparator group


Participant Flow:   Overall Study
    Computer-assisted Wean     Standard of Care  
STARTED     15     18  
COMPLETED     15     18  
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
Computer-assisted Wean Group assigned to the computer-assisted weaning program Intervention Group
Standard of Care

Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.

Comparator group

Total Total of all reporting groups

Baseline Measures
    Computer-assisted Wean     Standard of Care     Total  
Number of Participants  
[units: participants]
  15     18     33  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 21     60.5  ± 15.5     55.7  ± 18.9  
Gender  
[units: participants]
     
Female     5     7     12  
Male     10     11     21  
APACHE II Score [1]
[units: score]
Mean ± Standard Deviation
  23.3  ± 7.7     26.5  ± 7.1     25  ± 7.4  
[1] Acute Physiology and Chronic Health Evaluation Score Range 0-72 Higher score indicates more severe illness



  Outcome Measures
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1.  Primary:   Duration of Weaning   [ Time Frame: Continuous (median weaning duration was 2 days) ]

2.  Secondary:   Inpatient Mortality   [ Time Frame: 28 days ]

3.  Secondary:   Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)   [ Time Frame: Duration of weaning (median 2 days) ]

4.  Secondary:   Duration of ICU Stay   [ Time Frame: duration of study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Duration of Mechanical Ventilation   [ Time Frame: duration of study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Duration of Hospitalization   [ Time Frame: duration of study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Sedation Requirements   [ Time Frame: duration of study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Number of Spontaneous Breathing Trials Prior to Extubation   [ Time Frame: duration of study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
This trial was terminated early due to slow recruitment. It did not reach the target N of 220.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Allan Walkey, MD, MSc
Organization: Boston University School of Medicine
phone: 617-638-4860
e-mail: alwalkey@bu.edu


No publications provided


Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00606554     History of Changes
Other Study ID Numbers: H-26906
Study First Received: January 3, 2008
Results First Received: February 7, 2011
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board