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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Asynchrony rate defined as a percentage of the total respiratory rate | at 90 minutes |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel CONSTANTIN | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22661448 | Derived | 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. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059725 | Interactive Ventilatory Support |
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Patient comfort |
| at 90 minutes |