COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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. 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
Information provided by (Responsible Party):
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Device: Computer-assisted weaning program Behavioral: Standard of Care weaning Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Duration of Hospitalization [ Time Frame: from start of weaning to discharge from hospital, on average 1-2 weeks ]
  4. Inpatient Mortality [ Time Frame: 28 days ]
    proportion of patients in each arm who died in the hospital

  5. Sedation Requirements [ Time Frame: during weaning, on average 1-2 days ]
    measure was not recorded

  6. Number of Spontaneous Breathing Trials Prior to Extubation [ Time Frame: from start of weaning to liberation from ventilator, on average 1-2 days ]
  7. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00606554

Layout table for location information
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Layout table for investigator information
Principal Investigator: Christine C Reardon, MD Boston University
Additional Information:
Layout table for additonal information
Responsible Party: Boston Medical Center Identifier: NCT00606554    
Other Study ID Numbers: H-26906
First Posted: February 4, 2008    Key Record Dates
Results First Posted: August 17, 2011
Last Update Posted: December 11, 2017
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Boston Medical Center:
Respiratory Insufficiency
Ventilators, Mechanical
Ventilator Weaning
Therapy, Computer-Assisted
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases