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Completed

NCT Number: NCT00963066

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

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

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Key information

Conditions

Acute Lung Injury Lung Diseases Lung Injury Mechanical Ventilation Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de CAEN

Caen, 14000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSV - pressure suppot ventilation

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.

Other names: PSV

NAVA - Neurally Adjusted Ventilatory Assist

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.

Other names: NAVA - Flow

NAVA - EMG

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).

Primary outcomes

  1. Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)

    Time frame: 24 hours

Secondary outcomes

  1. Subject-ventilator synchrony

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

NAV-ALI: Effects of Different Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Patients Recovering Spontaneous Breathing After Acute Lung Injury: A Physiological Evaluation.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 21, 2009
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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