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

Not Applicable

Terminated

• Conditions: Respiratory Insufficiency
• Interventions: Device: Computer-assisted weaning program; Behavioral: Standard of Care weaning

• Registration Number: NCT00606554
• Lead Sponsor: Boston Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-02-04
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-02-07
• Results First Submitted QC: 2011-07-22
• Results First Posted: 2011-08-17
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-09
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-assisted weaning	Computer-assisted weaning program	Group assigned to the computer-assisted weaning program
Standard of care weaning	Standard of Care weaning	Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.

Primary Outcome Measures

Name	Time	Method
Duration of Weaning	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Hospitalization	from start of weaning to discharge from hospital, on average 1-2 weeks
Inpatient Mortality	28 days	proportion of patients in each arm who died in the hospital
Sedation Requirements	during weaning, on average 1-2 days	measure was not recorded
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)	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 ICU Stay	from start of weaning to discharge from ICU, on average 1-2 weeks	Duration of ICU stay after weaning initiation
Duration of Mechanical Ventilation	from start of weaning to liberation from ventilator, on average 1-2 days	Duration of mechanical ventilation from weaning initiation

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States