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

• ClinicalTrials.gov Identifier: NCT00606554
• Recruitment Status: Terminated
• First Posted: February 4, 2008
• Results First Posted: August 17, 2011
• Last Update Posted: December 11, 2017
• Sponsor: Boston Medical Center
• Information provided by (Responsible Party): Boston Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Insufficiency	Device: Computer-assisted weaning program; Behavioral: Standard of Care weaning	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation
• Study Start Date: January 2008
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Duration of Weaning [ Time Frame: 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 :

1. Duration of ICU Stay [ Time Frame: from start of weaning to discharge from ICU, on average 1-2 weeks ]
   Duration of ICU stay after weaning initiation
2. Duration of Mechanical Ventilation [ Time Frame: from start of weaning to liberation from ventilator, on average 1-2 days ]
   Duration of mechanical ventilation from weaning initiation
3. Duration of Hospitalization [ Time Frame: from start of weaning to discharge from hospital, on average 1-2 weeks ]
4. Inpatient Mortality [ Time Frame: 28 days ]
   proportion of patients in each arm who died in the hospital
5. Sedation Requirements [ Time Frame: during weaning, on average 1-2 days ]
   measure was not recorded
6. Number of Spontaneous Breathing Trials Prior to Extubation [ Time Frame: from start of weaning to liberation from ventilator, on average 1-2 days ]
7. Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston Medical Center

Investigators

• Principal Investigator: Christine C Reardon, MD; Boston University

More Information

Additional Information:

BUMC Pulmonary Center Home Page 

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT00606554
• Other Study ID Numbers: H-26906
• First Posted: February 4, 2008
• Results First Posted: August 17, 2011
• Last Update Posted: December 11, 2017
• Last Verified: November 2017

• 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

Keywords provided by Boston Medical Center:

Respiratory Insufficiency; Ventilators, Mechanical; Ventilator Weaning; Therapy, Computer-Assisted

Additional relevant MeSH terms:

Respiratory Insufficiency; Pulmonary Valve Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases