Mechanical Ventilation- Weaning and Thoracic Impedance Tomography

Study Overview
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Brief Summary
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The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM. This study is a multicenter randomized controlled open trial comparing variable, non-variable pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation for more than 24 hours who are able to be weaned. The aim of the study is to determine the duration of weaning from mechanical ventilation for each one of the above mentioned weaning methods

Official Title
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Comparison Between Automated Pressure Support Ventilation, Variable Pressure Support Ventilation and Non-variable Pressure Support Ventilation in Weaning From Mechanical Ventilation

Conditions
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Weaning From Mechanical Ventilation

Intervention / Treatment
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* Device: Variable PSV
* Device: Conventional PSV
* Device: Automated PSV
* Device: NAVA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age≥18 years duration of controlled mechanical ventilation≥ 24 h temperature≤ 39°C hemoglobin≥ 6 g/dl ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction - PaO2/FiO2≥150mmHg with positive end-expiratory pressure (PEEP)≤ 16 cmH2O ability of the patient to breathe spontaneously informed consent Exclusion Criteria: patient participated in another interventional trial within the last four weeks before enrollment peripheral neurological disease associated with impairment of the respiratory pump muscular disease associated with impairment of the respiratory pump unstable thorax with paradoxical chest wall movement planned surgery under general anesthesia within 72 hours difficult airway or intubation existing tracheotomy at ICU admission expected survival<72 hours home mechanical ventilation or on chronic oxygen therapy suspected or confirmed pregnancy

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: Variable PSV<br> | Device: Variable PSV<br>* Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. In patients ventilated with variable PSV, the pressure support variability is as high as possible (up to 100%), while not exceeding the maximal inspiratory pressure determined by the treating physician.<br>|
| Active Comparator: Conventional PSV<br> | Device: Conventional PSV<br>* Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. The adjustment of pressure support until extubation follows these rules for both non-variable and variable PSV groups: pressure support is gradually adjusted in decrements (or increments) of 0 to 5 cmH2O. PEEP is decreased in steps of 0 to 5 cmH2O; PEEP and FiO2 are adjusted to achieve a SaO2 ≥92%, with a PEEP ≥5 cmH2O.<br>|
| Active Comparator: Automated PSV<br> | Device: Automated PSV<br>* Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.Smart CareTM as total automated procedure will be used.<br>|
| Active Comparator: NAVA<br> | Device: NAVA<br>* NAVA level is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the Edi level was increased by step of 0,2 cm/h2o/ mcvolt, PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weaning time | weaning time defined as the time from randomization to successful extubation. | within 6 hours |