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

NCT01490710 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-09-04

No results posted yet for this study

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.

Conditions

  • Invasive Ventilatory Support

Interventions

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.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Nicolas JORAM, Doctor · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490710 on ClinicalTrials.gov