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

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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
Sponsor:
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

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

U.S. FDA Resources

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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00606554


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Christine C Reardon, MD Boston University

Additional Information:
Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00606554     History of Changes
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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases