Infantile Spinal Muscular Atrophy
Conditions
Keywords
Infantile Spinal Muscular Atrophy, Respiratory Decompensations
Brief summary
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.
Detailed description
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.
Interventions
DEVICENAVA
The study has 3 phases: 1. Phase 1: The patient is connected to the SERVOi® ventilator in classic VNI mode, which is parameterized according to the patient's needs and then maintained for 30min for measurements. 2. Phase 2: Switch to NAVA mode (1h). * Definition of NAVA parameters: The positive expiratory pressure will not be modified. The NAVA level (the proportionality factor that converts the EADi (microV) to the pressure level in cmH2O was first adjusted according to the actual assisted pressure in the patient in the normal VNI mode. * NAVA period: The ventilatory pressure, as well as the EADI is recorded continuously for 30min after a NAVA adaptation period of about 30min. 3. Phase 3: The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age above 1 year and under 18 years * Patient hospitalized in the pediatric intensive care unit. * Acute respiratory decompensation requiring non-invasive ventilation for more than 6 hours. * Patient with traditional NIV support less than 12 hours and still showing an indication for a non-invasive ventilatory support. * Affiliation to the French health insurance organism * Consent signed by the two holders of parental authority for the child participation in the research.
Exclusion criteria
* Contraindications to the use of NAVA or the setting up of a nasogastric tube. * Hemodynamic instability requiring the use of vasopressor amines, adrenaline, norepinephrine or dobutamine. * Severe respiratory instability requiring imminent intubation or FiO2\> 60%, or PaCO2\> 80 mmHg. * Limitation of life support treatments discussed or decided.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asynchrony percentage | At baseline | Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | At baseline | Frequency of obtaining an EADi signal |
| Efficacy and tolerance | At 30 minutes and 60 minutes | Efficacy and tolerance: during the whole of the study period (2h30), the monitoring of transcutaneous CO2 pressure (PtcCO2) will be collected. |
| Rate of recourse to intubation | At baseline | Rate of recourse to intubation, patient preference. |
Countries
France
Outcome results
None listed