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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

January 3, 2008
July 24, 2013
January 2008
May 2010   (final data collection date for primary outcome measure)
Duration of Weaning [ Time Frame: Continuous (median weaning duration was 2 days) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00606554 on ClinicalTrials.gov Archive Site
  • Duration of ICU Stay [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Duration of Mechanical Ventilation [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Duration of Hospitalization [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Inpatient Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    proportion of patients in each arm who died in the hospital
  • Sedation Requirements [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Number of Spontaneous Breathing Trials Prior to Extubation [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation) [ Time Frame: Duration of weaning (median 2 days) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Duration of hospitalization [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Sedation requirements [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Number of spontaneous breathing trials prior to extubation [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Complications (mortality during wean, ventilator-associated pneumonia, self extubation, re-intubation rate) [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Respiratory Insufficiency
  • Device: Computer-driven weaning program - Drager Evita Smartcare System
    Closed-loop, knowledge-based, computer driven weaning 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 wean
    Group assigned to the computer-assisted weaning program
    Intervention: Device: Computer-driven weaning program - Drager Evita Smartcare System
  • Active Comparator: Standard of Care
    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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606554
H-26906
No
Boston Medical Center
Boston Medical Center
Not Provided
Principal Investigator: Christine C Reardon, MD Boston University
Boston Medical Center
June 2011

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