NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Nantes University Hospital
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Assess the impact of NAVA ventilation on hemodynamic parameters
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- Blood pressure
- Lactate
- BNP
- Perfusion score
- Right cardiac work index
- Omega score
- Heart rate
- NIRS
- Blood gas