NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury

Study Overview
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Brief Summary
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Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist NAVA in patients who recover spontaneous breathing after acute lung injury.

Detailed Description
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Physiological evaluation of two modes of mechanical ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation, at different levels of ventilator assistance. Evaluation in term of physiological parameters: Tidal volume, Respiratory rate, Inspiratory effort, PaCO2, evaluation of subject-ventilator synchrony. Evaluation of physiological response to varying levels of ventilator assistance.

Official Title
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NAV-ALI: Effects of Different Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Patients Recovering Spontaneous Breathing After Acute Lung Injury: A Physiological Evaluation.

Conditions
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Acute Lung Injury, Mechanical Ventilation

Intervention / Treatment
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* Device: PSV - pressure suppot ventilation
* Device: NAVA - Neurally Adjusted Ventilatory Assist
* Device: NAVA - EMG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Hospitalized in intensive care unit Acute Lung Injury Intubated or tracheotomized and mechanically ventilated Exclusion Criteria: Hemodynamic instability Absence of consent

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pressure Support ventilation<br> | Device: PSV - pressure suppot ventilation<br>* Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Different levels of pressure support ventilator assistance are tested.<br>* Other names: PSV;|
| Experimental: NAVA flow triggering<br>Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering | Device: NAVA - Neurally Adjusted Ventilatory Assist<br>* Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Positive pressure, delivered by the machine, is driven using inspiratory flow trigger.<br>* Other names: NAVA - Flow;|
| Experimental: NAVA EMG triggering<br>Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram | Device: NAVA - EMG<br>* Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. The machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (Eadi). Eadi was obtained trhough a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-ventilator synchrony |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAVA, Acute Lung Injury, Pressure Support Ventilation, Intubation, Tracheostomy, Mechanical ventilation