Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II (NAVASI)
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|ClinicalTrials.gov Identifier: NCT03395795|
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : May 13, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Infantile Spinal Muscular Atrophy||Device: NAVA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Controlled Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II|
|Actual Study Start Date :||February 13, 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
Single arm trial, every patient enroll in this study will follow the same protocol with classic and NAVA mode non-invasive ventilation.
The study has 3 phases:
The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording.
- Asynchrony percentage [ Time Frame: At baseline ]Asynchrony percentage of non-synchronous breath cycles over all cycles of the measurement period, unaided breaths, self-initiated cycles.
- Feasibility [ Time Frame: At baseline ]Frequency of obtaining an EADi signal
- Feasibility [ Time Frame: At baseline ]Percentage of effective time spent in activated NAVA mode
- Efficacy and tolerance [ Time Frame: 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.
- Efficacy and tolerance [ Time Frame: At 30 minutes and 60 minutes ]Efficacy and tolerance: during the whole of the study period (2h30), evolution of respiratory rate will be collected.
- Efficacy and tolerance [ Time Frame: At 30 minutes and 60 minutes ]O2 saturation will be collected.
- Efficacy and tolerance [ Time Frame: At 30 minutes and 60 minutes ]FiO2 after 30 and 60 minutes under each ventilation mode will be collected.
- Rate of recourse to intubation [ Time Frame: At baseline ]Rate of recourse to intubation, patient preference.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395795
|Contact: Aben Essid, MD||+ 33 (6) 17 77 66 firstname.lastname@example.org|
|Service de pédiatrie, Hôpital Raymond Poincaré||Recruiting|
|Garches, Hauts-de-Seine, France, 92380|
|Study Chair:||Aben Essid, MD||Service de pédiatrie, Hôpital Raymond Poincaré|