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

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ClinicalTrials.gov Identifier: NCT00606554
Recruitment Status : Terminated (Slow recruitment of subjects)
First Posted : February 4, 2008
Results First Posted : August 17, 2011
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):

January 3, 2008
February 4, 2008
February 7, 2011
August 17, 2011
December 11, 2017
January 2008
May 2010   (Final data collection date for primary outcome measure)
Duration of Weaning [ Time Frame: Continuous (median weaning duration was 2 days) ]
Duration of weaning was assessed as the time from the initiation of weaning (randomization) to the time of successful extubation (defined as 48 hours free of mechanical ventilation). Patients were followed for the duration of hospitalization and the time of weaning onset and successful liberation from the ventilator was noted.
Duration of Weaning [ Time Frame: duration of study ]
Complete list of historical versions of study NCT00606554 on ClinicalTrials.gov Archive Site
  • Duration of ICU Stay [ Time Frame: from start of weaning to discharge from ICU, on average 1-2 weeks ]
    Duration of ICU stay after weaning initiation
  • Duration of Mechanical Ventilation [ Time Frame: from start of weaning to liberation from ventilator, on average 1-2 days ]
    Duration of mechanical ventilation from weaning initiation
  • Duration of Hospitalization [ Time Frame: from start of weaning to discharge from hospital, on average 1-2 weeks ]
  • Inpatient Mortality [ Time Frame: 28 days ]
    proportion of patients in each arm who died in the hospital
  • Sedation Requirements [ Time Frame: during weaning, on average 1-2 days ]
    measure was not recorded
  • Number of Spontaneous Breathing Trials Prior to Extubation [ Time Frame: from start of weaning to liberation from ventilator, on average 1-2 days ]
  • Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation) [ Time Frame: Duration of weaning (median 2 days) ]
    This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.
  • Duration of ICU Stay [ Time Frame: duration of study ]
  • Duration of Mechanical Ventilation [ Time Frame: duration of study ]
  • Duration of Hospitalization [ Time Frame: duration of study ]
  • Mortality [ Time Frame: 28 days ]
  • Sedation Requirements [ Time Frame: duration of study ]
  • Number of Spontaneous Breathing Trials Prior to Extubation [ Time Frame: duration of study ]
  • Complications (mortality during wean, ventilator-associated pneumonia, self extubation, re-intubation rate) [ Time Frame: duration of study ]
Not Provided
Not Provided
 
Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation
A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation
The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Respiratory Insufficiency
  • Device: Computer-assisted weaning program
    Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.
    Other Name: Drager Evita Smartcare System
  • Behavioral: Standard of Care weaning
    Evidence-based standard of care weaning process.
  • Experimental: Computer-assisted weaning
    Group assigned to the computer-assisted weaning program
    Intervention: Device: Computer-assisted weaning program
  • Active Comparator: Standard of care weaning
    Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
    Intervention: Behavioral: Standard of Care weaning
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than 18 years
  • Initiated on mechanical ventilation via endotracheal tube
  • Admitted to Medical Intensive Care Unit and Medical Intensive Care Unit Team (Harrison Avenue Campus, Menino Pavilion)
  • Requiring mechanical ventilation for more than 48 hours
  • Meets prespecified weaning criteria

Exclusion Criteria:

  • Do Not Resuscitate/Do Not Intubate order
  • Pregnancy
  • Mechanical ventilation initiated at another hospital
  • Cardiac arrest for more than 5 minutes with poor neurologic prognosis
  • Tracheostomy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00606554
H-26906
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Not Provided
Boston Medical Center
Boston Medical Center
Not Provided
Principal Investigator: Christine C Reardon, MD Boston University
Boston Medical Center
November 2017

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