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

Comparison of Automated Ventilator Controlled Weaning to Daily Spontaneous Breathing Trial Weaning Protocol in ICU Patients Following Prolonged Mechanical Ventilation.

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00813839

Enrollment

Registered

2008-12-23

Start date

2008-11-30

Completion date

2011-10-31

Last updated

2015-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation, Weaning

Keywords

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

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).

Interventions

OTHERdaily weaning trails

daily SmartCare vs SBT until extubation criteria met

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 * Patients with neurological injury in whom care is likely to be withdrawn * Patients with cervical spinal cord injury.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.

Design outcomes

Primary

Measure	Time frame
total duration of ventilatory support	28 days or extubation
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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026