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

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00606554
• Other study ID #: H-26906
• Status: Terminated
• Phase: N/A
• First received: January 3, 2008
• Last updated: November 9, 2017
• Start date: January 2008
• Est. completion date: May 2010

Study information

• Verified date: November 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

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

Behavioral:
• Standard of Care weaning
Evidence-based standard of care weaning process.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   BUMC Pulmonary Center Home Page