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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00963066
Enrollment
15
Registered
2009-08-21
Start date
2009-08-01
Completion date
2009-11-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury, Mechanical Ventilation

Keywords

NAVA, Acute Lung Injury, Pressure Support Ventilation, Intubation, Tracheostomy, Mechanical ventilation

Brief summary

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

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.

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.

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.

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).

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)24 hours

Secondary

MeasureTime frame
Subject-ventilator synchrony24 hours

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNicolas TERZI, MD

University Hospital, Caen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026