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

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ClinicalTrials.gov Identifier: NCT01490710
Recruitment Status : Terminated
First Posted : December 13, 2011
Last Update Posted : September 4, 2013
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


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
Allocation: Randomized
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

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.


Primary Outcome Measures :
  1. 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 :
  1. Omega score
    SaO2/SaO2-SvO2

  2. Heart rate
  3. Blood pressure
  4. NIRS
  5. Blood gas
  6. Lactate
  7. BNP
  8. Perfusion score
  9. Right cardiac work index
    if available



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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


Locations
France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Nicolas JORAM, Doctor Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01490710     History of Changes
Other Study ID Numbers: 11/6-H
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013

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