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) ]
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