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

This study is currently recruiting participants.
Verified December 2011 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01490710
First received: December 7, 2011
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention
Invasive Ventilatory Support
 Other: collection of clinical and biological parameters
Other: assign optimal ventilatory mode

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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:
  • Omega score
    SaO2/SaO2-SvO2

  • Heart rate
  • Blood pressure
  • NIRS
  • Blood gas
  • Lactate
  • BNP
  • Perfusion score
  • Right cardiac work index
    if available


Estimated Enrollment: 50
Study Start Date: November 2011
Intervention Details:
    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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490710

Contacts
Contact: Nicolas JORAM, Doctor +33 2 40 08 34 83 nicolas.joram@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Nicolas JORAM, Doctor     +33 2 40 08 34 83     nicolas.joram@chu-nantes.fr    
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Nicolas JORAM, Doctor Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01490710     History of Changes
Other Study ID Numbers: 11/6-H
Study First Received: December 7, 2011
Last Updated: December 13, 2011
Health Authority: France : NA (This research did not enter in the French legislation of biomedical researches, and so did not require an Authorities approval)

Keywords provided by Nantes University Hospital:
NAVA
Hemodynamic
Cardiac Index
Children with admission weight > 5kg

ClinicalTrials.gov processed this record on May 16, 2013