Clinical Trial: Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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 Summary:

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.


Sponsor: University Hospital, Clermont-Ferrand

Current Primary Outcome: Asynchrony rate defined as a percentage of the total respiratory rate [ Time Frame: at 90 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Clermont-Ferrand

Dates:
Date Received: July 7, 2011
Date Started: July 2011
Date Completion:
Last Updated: July 4, 2014
Last Verified: July 2014