NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization

Study Overview
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Brief Summary
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Despite spectacular advances since the 90s mechanical ventilation used in intensive care units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a significant morbidity and mortality. NAVA (Neurally Adjusted Assist Ventilation) ventilatory support, provides synchronous support, proportionate to patient's respiratory efforts. More physiological, this mode would decline its efficacy on patient hemodynamic response. However, to date, no study has focused on hemodynamic impact of NAVA. This is precisely the purpose of NAVADYN11 study, which aims to assess NAVA efficacy on cardiac index in pediatric intensive care unit.

Official Title
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NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization

Conditions
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Invasive Ventilatory Support

Intervention / Treatment
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* Other: collection of clinical and biological parameters
* Other: assign optimal ventilatory mode


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Servo-i with NAVA available at patient admission Sedation protocol compatible with NAVA functioning Parental consent Non inclusion criteria: Digestive pathology incompatible with gastric tube. Deep sedation required defined by score ComfortB <11 (cranial traumatism…) Brain damage incompatible with spontaneous ventilation Duration of intubation too short for investigation Exclusion criteria: Clinical worsening requiring treatment and/or management inconsistent with NAVADYN11 research (CPR, emergency surgery ...). However, the investigator is allowed to reiterate investigation when patient stabilized.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: collection of clinical and biological parameters|Investigation focal lies in hemodynamic monitoring during the last 10 minutes (Cardiac Index Assessment and clinico-biological parameters as: ventilatory and respiratory parameters, NIRS, GDS, Omega Score, heart rate, blood pressure, lactate, BNP, perfusion coefficient…)|
|Other: assign optimal ventilatory mode|End of study: At the end of the second session, clinician will assign optimal ventilatory mode regarding patient clinical response.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the impact of NAVA ventilation on hemodynamic parameters | Assess the impact of NAVA ventilation on hemodynamic parameters in children hospitalized in a Paediatric Intensive Care Unit. Endpoint evaluation consists in a non-invasive measurement of cardiac index by esophageal doppler. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega score | SaO2/SaO2-SvO2 |  | 
| Heart rate |  |  | 
| Blood pressure |  |  | 
| NIRS |  |  | 
| Blood gas |  |  | 
| Lactate |  |  | 
| BNP |  |  | 
| Perfusion score |  |  | 
| Right cardiac work index | if available |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAVA, Hemodynamic, Cardiac Index, Children with admission weight > 5kg