Respiratory Insufficiency Clinical Trial
Official title:
Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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