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

Phase 4

Withdrawn

• Conditions: Weaning; Mechanical Ventilation
• Interventions: Other: daily weaning trails

• Registration Number: NCT00813839
• Lead Sponsor: University of California, San Francisco

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-06
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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• Patients with neurological injury in whom care is likely to be withdrawn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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 spontaneous breathing Trial	daily weaning trails	daily SBT on minimum pressure support
1 SmartCare	daily weaning trails	automated ventilator controlled adjustment of pressure support

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
clinical staff time requirements	during active weaning period
reintubations within 48 hours	48 hrs
ICU and hospital length of stay	total time of ICU and hospital stay
sedation and analgesic requirements	28 days or extubation

Trial Locations

Locations (1)

San Francisco General Hospital, UCSF Dept. of Anesthesia; 🇺🇸 San Francisco, California, United States