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

NCT00606554 | Terminated Results FDA Device

• 1 other identifier: H-26906
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Insufficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Duration of ICU Stay

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

• Duration of Mechanical Ventilation

  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

  28 days

• Sedation Requirements

  during weaning, on average 1-2 days

Study Arms (2)

Computer-assisted weaning

EXPERIMENTAL

Group assigned to the computer-assisted weaning program

Device: Computer-assisted weaning program

Standard of care weaning

ACTIVE COMPARATOR

Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.

Behavioral: Standard of Care weaning

Interventions

Computer-assisted weaning program DEVICE

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

Also known as: Drager Evita Smartcare System

Computer-assisted weaning

Standard of Care weaning BEHAVIORAL

Evidence-based standard of care weaning process.

Standard of care weaning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Links

• BUMC Pulmonary Center Home Page

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Limitations and Caveats

This trial was terminated early due to slow recruitment. It did not reach the target N of 220.

Results Point of Contact

• Title: Allan Walkey, MD, MSc
• Organization: Boston University School of Medicine

alwalkey@bu.edu

617-638-4860

Study Officials

• Christine C Reardon, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: February 4, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 11, 2017
• Results First Posted: August 17, 2011

Record last verified: 2017-11

Locations

US (1)