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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Mechanical Ventilation Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 SmartCare

automated ventilator controlled adjustment of pressure support

Group Type EXPERIMENTAL

daily weaning trails

Intervention Type OTHER

daily SmartCare vs SBT until extubation criteria met

2 spontaneous breathing Trial

daily SBT on minimum pressure support

Group Type ACTIVE_COMPARATOR

daily weaning trails

Intervention Type OTHER

daily SmartCare vs SBT until extubation criteria met

Interventions

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daily weaning trails

daily SmartCare vs SBT until extubation criteria met

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No