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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status and phase

Withdrawn
Phase 4

Conditions

Weaning
Mechanical Ventilation

Treatments

Other: daily weaning trails

Study type

Interventional

Funder types

Other

Identifiers

NCT00813839
H60971-32402-02

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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  • Patients with neurological injury in whom care is likely to be withdrawn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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

1 SmartCare
Experimental group
Description:
automated ventilator controlled adjustment of pressure support
Treatment:
Other: daily weaning trails
2 spontaneous breathing Trial
Active Comparator group
Description:
daily SBT on minimum pressure support
Treatment:
Other: daily weaning trails

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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