Invasive Ventilatory Support
Conditions
Keywords
NAVA, Hemodynamic, Cardiac Index, Children with admission weight > 5kg
Brief summary
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.
Interventions
OTHERcollection 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…)
OTHERassign optimal ventilatory mode
End of study: At the end of the second session, clinician will assign optimal ventilatory mode regarding patient clinical response.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | — | — |
| Blood pressure | — | — |
| NIRS | — | — |
| Blood gas | — | — |
| Omega score | — | SaO2/SaO2-SvO2 |
| BNP | — | — |
| Perfusion score | — | — |
| Right cardiac work index | — | if available |
| Lactate | — | — |
Countries
France
Outcome results
None listed