NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury

NCT ID: NCT00963066

Last Updated: 2010-03-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-11-30

Brief Summary

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Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist "NAVA" in patients who recover spontaneous breathing after acute lung injury.

Detailed Description

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Physiological evaluation of two modes of mechanical ventilation: Neurally Adjusted Ventilatory Assist (NAVA) vs Pressure Support Ventilation, at different levels of ventilator assistance.

Evaluation in term of physiological parameters: Tidal volume, Respiratory rate, Inspiratory effort, PaCO2, evaluation of subject-ventilator synchrony.

Evaluation of physiological response to varying levels of ventilator assistance.

Conditions

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Acute Lung Injury Mechanical Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Pressure Support ventilation

Group Type ACTIVE_COMPARATOR

PSV - pressure suppot ventilation

Intervention Type DEVICE

Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Different levels of pressure support ventilator assistance are tested.

NAVA flow triggering

Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering

Group Type EXPERIMENTAL

NAVA - Neurally Adjusted Ventilatory Assist

Intervention Type DEVICE

Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Positive pressure, delivered by the machine, is driven using inspiratory flow trigger.

NAVA EMG triggering

Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram

Group Type EXPERIMENTAL

NAVA - EMG

Intervention Type DEVICE

Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. The machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (Eadi). Eadi was obtained trhough a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden).

Interventions

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PSV - pressure suppot ventilation

Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Different levels of pressure support ventilator assistance are tested.

Intervention Type DEVICE

NAVA - Neurally Adjusted Ventilatory Assist

Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Positive pressure, delivered by the machine, is driven using inspiratory flow trigger.

Intervention Type DEVICE

NAVA - EMG

Partial ventilator support with new partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. The machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (Eadi). Eadi was obtained trhough a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden).

Intervention Type DEVICE

Other Intervention Names

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PSV NAVA - Flow

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Hospitalized in intensive care unit
* Acute Lung Injury
* Intubated or tracheotomized and mechanically ventilated

Exclusion Criteria

* Hemodynamic instability
* Absence of consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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CHU de CAEN

Principal Investigators

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Nicolas TERZI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Caen

Locations

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CHU de CAEN

Caen, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00583-54

Identifier Type: -

Identifier Source: org_study_id

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