Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensati… (NCT03395795) | Clinical Trial Compass
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 range
1 Year – 18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.