Infantile Spinal Muscular Atrophy Clinical Trial
— NAVASIOfficial title:
Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II
Verified date | March 2022 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1 |
Est. completion date | October 5, 2021 |
Est. primary completion date | December 17, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Service de pédiatrie, Hôpital Raymond Poincaré | Garches | Hauts-de-Seine |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asynchrony percentage | Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles. | At baseline | |
Secondary | Feasibility | Frequency of obtaining an EADi signal | At baseline | |
Secondary | Feasibility | Percentage of effective time spent in activated NAVA mode | At baseline | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Efficacy and tolerance | O2 saturation will be collected. | At 30 minutes and 60 minutes | |
Secondary | Efficacy and tolerance | FiO2 after 30 and 60 minutes under each ventilation mode will be collected. | At 30 minutes and 60 minutes | |
Secondary | Rate of recourse to intubation | Rate of recourse to intubation, patient preference. | At baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06152302 -
Test of Aquatic Mobility of SMA Infants
|
N/A |