Clinical trial NCT01426178: Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
Official title: Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Insufficiency
Keywords: Respiratory Insufficiency
Respiration, Artificial
Intermittent Positive-Pressure Ventilation
Neurally Adjusted Ventilatory Assist
Non Invasive Ventilation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2011-08-31
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Asynchrony rate defined as a percentage of the total respiratory rate
timeFrame: at 90 minutes
Secondary outcomes:
measure: - Number of patients presenting a high asynchrony rate (>10%)
timeFrame: at 90 minutes
measure: Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set
timeFrame: at 90 minutes
measure: Patient comfort
timeFrame: at 90 minutes
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Michel CONSTANTIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.