- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00606554
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
Status
Terminated
Conditions
Intervention / Treatment
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:
|
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
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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)
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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.
Sponsor
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.
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-26906
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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