Clinical Trial of a Computer-Driven Weaning System for Patients Requiring Mechanical Ventilation - Full Text View

Sponsored by:	Boston Medical Center
Information provided by:	Boston Medical Center
ClinicalTrials.gov Identifier:	NCT00606554

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:

Duration of Weaning [ Time Frame: duration of study ] [ Designated as safety issue: No ]

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 ]
Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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 (mortality during wean, ventilator-associated pneumonia, self extubation, re-intubation rate) [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	220
Study Start Date:	January 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Computer-assisted wean: Experimental 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.
Standard of Care: Active Comparator 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 MICU Team (Harrison Avenue Campus, Menino Pavilion)
Requiring mechanical ventilation for more than 48 hours
Meets prespecified weaning criteria

Exclusion Criteria:

DNR/DNI order
Pregnancy
Mechanical ventilation initiated at another hospital
Cardiac arrest for more than 5 minutes with poor neurologic prognosis
Tracheostomy

Contacts and Locations

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:

BUMC Pulmonary Center Home Page This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Boston University Medical Center ( Christine Reardon, MD )
Study ID Numbers:	H-26906
Study First Received:	January 3, 2008
Last Updated:	January 22, 2008
ClinicalTrials.gov Identifier:	NCT00606554 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Medical Center:

Respiratory Insufficiency
Ventilators, Mechanical
Ventilator Weaning
Therapy, Computer-Assisted

Ventilators, Mechanical
Ventilator Weaning
Therapy, Computer-Assisted

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

Additional relevant MeSH terms:

Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on September 03, 2009