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

NCT ID: NCT00606554

Last Updated: 2017-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Insufficiency

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Computer-assisted weaning

Group assigned to the computer-assisted weaning program

Group Type EXPERIMENTAL

Computer-assisted weaning program

Intervention Type DEVICE

Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.

Standard of care weaning

Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.

Group Type ACTIVE_COMPARATOR

Standard of Care weaning

Intervention Type BEHAVIORAL

Evidence-based standard of care weaning process.

Interventions

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Computer-assisted weaning program

Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.

Intervention Type DEVICE

Standard of Care weaning

Evidence-based standard of care weaning process.

Intervention Type BEHAVIORAL

Other Intervention Names

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Drager Evita Smartcare System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine C Reardon, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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http://www.bumc.bu.edu/pulmonary

BUMC Pulmonary Center Home Page

Other Identifiers

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H-26906

Identifier Type: -

Identifier Source: org_study_id