CompletedNot Applicable

Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II

France1 participantsStarted 2018-02-13

Plain-language 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.

Who can participate

Age range1 Year – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Asynchrony percentage

Timeframe: At baseline

Trial details

NCT IDNCT03395795

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-17