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

Study Overview
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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.

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

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: Computer-assisted weaning program
* Behavioral: Standard of Care weaning


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer-assisted weaning<br>Group assigned to the computer-assisted weaning program | Device: Computer-assisted weaning program<br>* Closed-loop, knowledge-based, computer-assisted wean program initiated at the start of ventilator weaning.<br>* Other names: Drager Evita Smartcare System;|
| Active Comparator: Standard of care weaning<br>Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation. | Behavioral: Standard of Care weaning<br>* Evidence-based standard of care weaning process.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ICU Stay | Duration of ICU stay after weaning initiation | from start of weaning to discharge from ICU, on average 1-2 weeks | 
| Duration of Mechanical Ventilation | Duration of mechanical ventilation from weaning initiation | from start of weaning to liberation from ventilator, on average 1-2 days | 
| Duration of Hospitalization |  | from start of weaning to discharge from hospital, on average 1-2 weeks | 
| Inpatient Mortality | proportion of patients in each arm who died in the hospital | 28 days | 
| Sedation Requirements | measure was not recorded | during weaning, on average 1-2 days | 
| Number of Spontaneous Breathing Trials Prior to Extubation |  | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Insufficiency, Ventilators, Mechanical, Ventilator Weaning, Therapy, Computer-Assisted