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

This study has been terminated.
(Slow recruitment of subjects)
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00606554
First received: January 3, 2008
Last updated: July 24, 2013
Last verified: June 2011
  Purpose

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 Intervention
Respiratory Insufficiency
Device: Computer-driven weaning program - Drager Evita Smartcare System
Behavioral: Standard of Care weaning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Duration of Weaning [ Time Frame: Continuous (median weaning duration was 2 days) ] [ Designated as safety issue: No ]
    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:
  • Duration of ICU Stay [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Duration of Mechanical Ventilation [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Duration of Hospitalization [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Inpatient Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    proportion of patients in each arm who died in the hospital

  • Sedation Requirements [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Number of Spontaneous Breathing Trials Prior to Extubation [ Time Frame: duration of study ] [ Designated as safety issue: No ]
  • Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation) [ Time Frame: Duration of weaning (median 2 days) ] [ Designated as safety issue: Yes ]
    This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.


Enrollment: 33
Study Start Date: January 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computer-assisted wean
Group assigned to the computer-assisted weaning program
Device: Computer-driven weaning program - Drager Evita Smartcare System
Closed-loop, knowledge-based, computer driven weaning program initiated at the start of ventilator weaning.
Other Name: Drager Evita Smartcare System
Active Comparator: Standard of Care
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00606554     History of Changes
Other Study ID Numbers: H-26906
Study First Received: January 3, 2008
Results First Received: February 7, 2011
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Respiratory Insufficiency
Ventilators, Mechanical
Ventilator Weaning
Therapy, Computer-Assisted

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014