Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Insufficiency||Device: Computer-assisted weaning program Behavioral: Standard of Care weaning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Experimental: Computer-assisted weaning
Group assigned to the computer-assisted weaning program
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
Active Comparator: Standard of care weaning
Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
Behavioral: Standard of Care weaning
Evidence-based standard of care weaning process.
- 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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606554
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Christine C Reardon, MD||Boston University|