NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01490710|
Recruitment Status : Terminated
First Posted : December 13, 2011
Last Update Posted : September 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Invasive Ventilatory Support||Other: collection of clinical and biological parameters Other: assign optimal ventilatory mode||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization|
|Study Start Date :||November 2011|
- 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.
- Assess the impact of NAVA ventilation on hemodynamic parametersAssess 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.
- Omega scoreSaO2/SaO2-SvO2
- Heart rate
- Blood pressure
- Blood gas
- Perfusion score
- Right cardiac work indexif available
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490710
|Nantes University Hospital|
|Nantes, France, 44093|
|Principal Investigator:||Nicolas JORAM, Doctor||Nantes University Hospital|