Automated Ventilator Controlled Weaning vs Daily Spontaneous Breathing Trial in Difficult to Wean ICU Patients

NCT00813839 | Withdrawn Phase 4

• 1 other identifier: H60971-32402-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare Drager Smart Care (SC), a commercially available automated ventilator controlled weaning mode to the current daily spontaneous breathing trial (SBT) weaning protocol. The study is designed to determine if automated ventilator controlled weaning can reduce total duration of intubation following mechanical ventilation in ICU patients requiring prolonged mechanical ventilation (\>72 hours).

Conditions

Mechanical Ventilation; Weaning

Keywords

SmartCare; Spontaneous Breathing Trials; Mechanical Ventilation; Weaning; Patients requiring prolonged mechanical ventilation (>72 hours)

Outcome Measures

Primary Outcomes (4)

• weaning time to successful spontaneous breathing trial

  28 days or extubation

• weaning time to successful extubation

  28 days or extubation

• ventilator weaning days

  28 days or extubation

• total duration of ventilatory support

  28 days or extubation

Secondary Outcomes (4)

• reintubations within 48 hours

  48 hrs

• sedation and analgesic requirements

  28 days or extubation

• ICU and hospital length of stay

  total time of ICU and hospital stay

• clinical staff time requirements

  during active weaning period

Study Arms (2)

1 SmartCare

EXPERIMENTAL

automated ventilator controlled adjustment of pressure support

Other: daily weaning trails

2 spontaneous breathing Trial

ACTIVE COMPARATOR

daily SBT on minimum pressure support

Other: daily weaning trails

Interventions

daily weaning trails OTHER

daily SmartCare vs SBT until extubation criteria met

1 SmartCare; 2 spontaneous breathing Trial

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Intubated with endotracheal tube
• Requiring mechanical ventilation for \> 72 hours
• Meets weaning criteria: Improvement or resolution of the underlying process that precipitated need for mechanical ventilation, PaO2 ≥ 60 mm Hg on PEEP and FiO2 Requirements of ≤ 8 cm H2O and FiO2 ≤ 0.50, Stable oxygenation: PEEP and FiO2 requirements not increased in the past 24 hrs, Ability to initiate an inspiratory effort and trigger the ventilator, Subject enrollment approved by the primary service attending physician

You may not qualify if:

• Pregnancy
• Patients with tracheostomy or planned tracheostomy prior to attempt to extubate
• Patients with known airway patency issues that are anticipated to delay extubation.
• Patients with neurological injury in whom care is likely to be withdrawn
• Patients with cervical spinal cord injury.
• Prospective subject or surrogate consenter does not fully understand the implications of the study because of a language barrier.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital, UCSF Dept. of Anesthesia

San Francisco, California, 94110, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: December 23, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 8, 2015

Record last verified: 2015-05

Locations

US (1)