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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation

Brief Summary: 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.

Detailed Summary:
Sponsor: Boston Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: Duration of Weaning [ Time Frame: duration of study ]

Current Secondary Outcome:

  • 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 ]
  • Inpatient Mortality [ Time Frame: 28 days ]
    proportion of patients in each arm who died in the hospital
  • Sedation Requirements [ Time Frame: duration of study ]
  • Number of Spontaneous Breathing Trials Prior to Extubation [ Time Frame: duration of study ]
  • 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.


Original Secondary Outcome:

  • 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 ]


Information By: Boston Medical Center

Dates:
Date Received: January 3, 2008
Date Started: January 2008
Date Completion:
Last Updated: July 24, 2013
Last Verified: June 2011