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

NCT ID: NCT01490710

Last Updated: 2013-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Invasive Ventilatory Support

Keywords

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NAVA Hemodynamic Cardiac Index Children with admission weight > 5kg

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

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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…)

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Servo-i with NAVA available at patient admission
* Sedation protocol compatible with NAVA functioning
* Parental consent


* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas JORAM, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

References

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Liet JM, Barriere F, Gaillard-Le Roux B, Bourgoin P, Legrand A, Joram N. Physiological effects of invasive ventilation with neurally adjusted ventilatory assist (NAVA) in a crossover study. BMC Pediatr. 2016 Nov 8;16(1):180. doi: 10.1186/s12887-016-0717-4.

Reference Type DERIVED
PMID: 27821162 (View on PubMed)

Other Identifiers

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11/6-H

Identifier Type: -

Identifier Source: org_study_id