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

Primary Purpose

Respiratory Insufficiency

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-assisted weaning program
Standard of Care weaning
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Respiratory Insufficiency, Ventilators, Mechanical, Ventilator Weaning, Therapy, Computer-Assisted

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Computer-assisted weaning

Standard of care weaning

Arm Description

Group assigned to the computer-assisted weaning program

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

Outcomes

Primary Outcome Measures

Duration of Weaning
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
Duration of ICU stay after weaning initiation
Duration of Mechanical Ventilation
Duration of mechanical ventilation from weaning initiation
Duration of Hospitalization
Inpatient Mortality
proportion of patients in each arm who died in the hospital
Sedation Requirements
measure was not recorded
Number of Spontaneous Breathing Trials Prior to Extubation
Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)
This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.

Full Information

First Posted
January 3, 2008
Last Updated
November 9, 2017
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00606554
Brief Title
Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation
Official Title
A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment of subjects
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Respiratory Insufficiency, Ventilators, Mechanical, Ventilator Weaning, Therapy, Computer-Assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer-assisted weaning
Arm Type
Experimental
Arm Description
Group assigned to the computer-assisted weaning program
Arm Title
Standard of care weaning
Arm Type
Active Comparator
Arm Description
Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.
Intervention Type
Device
Intervention Name(s)
Computer-assisted weaning program
Other Intervention Name(s)
Drager Evita Smartcare System
Intervention Description
Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care weaning
Intervention Description
Evidence-based standard of care weaning process.
Primary Outcome Measure Information:
Title
Duration of Weaning
Description
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.
Time Frame
Continuous (median weaning duration was 2 days)
Secondary Outcome Measure Information:
Title
Duration of ICU Stay
Description
Duration of ICU stay after weaning initiation
Time Frame
from start of weaning to discharge from ICU, on average 1-2 weeks
Title
Duration of Mechanical Ventilation
Description
Duration of mechanical ventilation from weaning initiation
Time Frame
from start of weaning to liberation from ventilator, on average 1-2 days
Title
Duration of Hospitalization
Time Frame
from start of weaning to discharge from hospital, on average 1-2 weeks
Title
Inpatient Mortality
Description
proportion of patients in each arm who died in the hospital
Time Frame
28 days
Title
Sedation Requirements
Description
measure was not recorded
Time Frame
during weaning, on average 1-2 days
Title
Number of Spontaneous Breathing Trials Prior to Extubation
Time Frame
from start of weaning to liberation from ventilator, on average 1-2 days
Title
Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)
Description
This outcome is a composite outcome of the total number of participants with any one of the above-listed weaning-associated complications.
Time Frame
Duration of weaning (median 2 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine C Reardon, MD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.bumc.bu.edu/pulmonary
Description
BUMC Pulmonary Center Home Page

Learn more about this trial

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

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