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CompletedNCT00963066Updated Apr 2, 2026

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

An interventional study of PSV - pressure suppot ventilation and NAVA - Neurally Adjusted Ventilatory Assist in Acute Lung Injury and Mechanical Ventilation, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Acute Lung Injury
  • Mechanical Ventilation

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Keywords

  • NAVA
  • Acute Lung Injury
  • Pressure Support Ventilation
  • Intubation
  • Tracheostomy
  • Mechanical ventilation
03

In context

Acute Lung Injury

989 studies on the registry are indexed under Acute Lung Injury; 156 are open to participants now.

This study's planned enrollment of 15 is below the median of 54 across 561 interventional studies indexed under Acute Lung Injury.

Browse Acute Lung Injury studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hemodynamic instability
  • Absence of consent
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Active comparator
    Pressure Support ventilation

    Device: PSV - pressure suppot ventilation

  • Experimental
    NAVA flow triggering

    Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering

    Device: NAVA - Neurally Adjusted Ventilatory Assist

  • Experimental
    NAVA EMG triggering

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

    Device: NAVA - EMG

Interventions

  • DevicePSV - 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.

    Also known as: PSV

  • DeviceNAVA - 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.

    Also known as: NAVA - Flow

  • DeviceNAVA - 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).

06

What researchers measure

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

07

Study locations

1 site
  • CHU de CAEN
    Caen, 14000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00963066
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Aug 21, 2009
Start date
Aug 2009
Primary completion
Nov 2009
Completion
Nov 2009
Last update
Apr 2, 2026

Study contacts

Nicolas TERZI, MD
principal investigator · University Hospital, Caen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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