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.
1 other identifier
interventional
15
1 country
1
Brief Summary
Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist "NAVA" in patients who recover spontaneous breathing after acute lung injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedApril 2, 2026
March 1, 2010
3 months
August 12, 2009
March 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
24 hours
Secondary Outcomes (1)
Subject-ventilator synchrony
24 hours
Study Arms (3)
Pressure Support ventilation
ACTIVE COMPARATORNAVA flow triggering
EXPERIMENTALSpontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering
NAVA EMG triggering
EXPERIMENTALSpontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram
Interventions
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.
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.
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).
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- Hospitalized in intensive care unit
- Acute Lung Injury
- Intubated or tracheotomized and mechanically ventilated
You may not qualify if:
- Hemodynamic instability
- Absence of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de CAEN
Caen, 14000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas TERZI, MD
University Hospital, Caen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2009
First Posted
August 21, 2009
Study Start
August 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
April 2, 2026
Record last verified: 2010-03