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

Boston Medical Center33 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiratory Insufficiency

Interventions

Computer-assisted weaning programDEVICE

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

Standard of Care weaningBEHAVIORAL

Evidence-based standard of care weaning process.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Continuous (median weaning duration was 2 days)

Secondary Outcomes

Duration of ICU Stay

Duration of ICU stay after weaning initiation

Time frame: from start of weaning to discharge from ICU, on average 1-2 weeks

Duration of Mechanical Ventilation

Duration of mechanical ventilation from weaning initiation

Time frame: 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

Inpatient Mortality

proportion of patients in each arm who died in the hospital

Time frame: 28 days

Sedation Requirements

measure was not recorded

Time frame: 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

Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)

Data from ClinicalTrials.gov

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