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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2017-A02785-48 | Other Identifier | ANSM |
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The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient.
To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.
This is a prospective, interventional, sequential, open-label research involving ASI II children with acute respiratory decompensation requiring ventilatory support by NIV. Airway pressure, transcutaneous CO2 monitoring and hemodynamic parameters will be recorded continuously during the study, after inclusion of the patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | Single arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAVA | Device | The study has 3 phases:
The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording. |
| Measure | Description | Time Frame |
|---|---|---|
| Asynchrony percentage | Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles. | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Frequency of obtaining an EADi signal | At baseline |
| Feasibility | Percentage of effective time spent in activated NAVA mode |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aben Essid, MD | Service de pédiatrie, Hôpital Raymond Poincaré | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de pédiatrie, Hôpital Raymond Poincaré | Garches | Hauts-de-Seine | 92380 | France |
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|
| At baseline |
| Efficacy and tolerance | Efficacy and tolerance: during the whole of the study period (2h30), the monitoring of transcutaneous CO2 pressure (PtcCO2) will be collected. | At 30 minutes and 60 minutes |
| Efficacy and tolerance | Efficacy and tolerance: during the whole of the study period (2h30), evolution of respiratory rate will be collected. | At 30 minutes and 60 minutes |
| Efficacy and tolerance | O2 saturation will be collected. | At 30 minutes and 60 minutes |
| Efficacy and tolerance | FiO2 after 30 and 60 minutes under each ventilation mode will be collected. | At 30 minutes and 60 minutes |
| Rate of recourse to intubation | Rate of recourse to intubation, patient preference. | At baseline |
| ID | Term |
|---|---|
| D014897 | Spinal Muscular Atrophies of Childhood |
| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D016472 | Motor Neuron Disease |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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