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

Study Overview
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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).

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

Conditions
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Mechanical Ventilation, Weaning

Intervention / Treatment
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* Other: daily weaning trails


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 Patients with neurological injury in whom care is likely to be withdrawn Patients with cervical spinal cord injury.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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 SmartCare<br>automated ventilator controlled adjustment of pressure support | Other: daily weaning trails<br>* daily SmartCare vs SBT until extubation criteria met<br>|
| Active Comparator: 2 spontaneous breathing Trial<br>daily SBT on minimum pressure support | Other: daily weaning trails<br>* daily SmartCare vs SBT until extubation criteria met<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SmartCare, Spontaneous Breathing Trials, Mechanical Ventilation, Weaning, Patients requiring prolonged mechanical ventilation (>72 hours)