Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

Study Overview
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Brief Summary
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Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support (PSV) mode. The purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of NAVA.

Detailed Description
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After written information and consent, patients are randomised in two groups: NAVA first or PSV first. They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter. A standardised set of 1 hour of non-invasive ventilation is started. Depending on the randomisation group, patients start with a 30 minutes set of NIV with NAVA settings or with a 30 minutes set of NIV with PSV settings. A 30-minute watch-out period is then delivered with no mechanical ventilation. Then a second 30-minute set of NIV in the other settings (NAVA or PSV depending on the randomisation) is delivered. During each set of NIV, flow, volume, pressure and EADi are recorded during 10 minutes, after a 10-minute period of equilibration. Recordings will be processed by two blind investigators in order to count the number of asynchronies. In case of disagreement between investigators, a third one will be interviewed.

Official Title
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Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patient older then 18 years Patient requiring first non invasive ventilation set because of acute respiratory failure Exclusion Criteria: Patients protected by the law Pregnant women

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)|After written information and consent, patients are randomised in two groups: NAVA first or PSV first. They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchrony rate defined as a percentage of the total respiratory rate |  | at 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Number of patients presenting a high asynchrony rate (>10%) |  | at 90 minutes | 
| Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set |  | at 90 minutes | 
| Patient comfort |  | at 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Insufficiency, Respiration, Artificial, Intermittent Positive-Pressure Ventilation, Neurally Adjusted Ventilatory Assist, Non Invasive Ventilation