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

November 9, 2017 updated by: Boston Medical Center

A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computer-assisted weaning
Group assigned to the computer-assisted weaning program
Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.
Other Names:
  • 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.
Evidence-based standard of care weaning process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Continuous (median weaning duration was 2 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from start of weaning to discharge from ICU, on average 1-2 weeks
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
from start of weaning to liberation from ventilator, on average 1-2 days
Duration of Hospitalization
Time Frame: from start of weaning to discharge from hospital, on average 1-2 weeks
from start of weaning to discharge from hospital, on average 1-2 weeks
Inpatient Mortality
Time Frame: 28 days
proportion of patients in each arm who died in the hospital
28 days
Sedation Requirements
Time Frame: during weaning, on average 1-2 days
measure was not recorded
during weaning, on average 1-2 days
Number of Spontaneous Breathing Trials Prior to Extubation
Time Frame: from start of weaning to liberation from ventilator, on average 1-2 days
from start of weaning to liberation from ventilator, on average 1-2 days
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.
Duration of weaning (median 2 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christine C Reardon, MD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 3, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

February 4, 2008

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

November 9, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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