Acute Lung InjuryNCT00963066
NAV-ALI: Neurally Adjusted Ventilatory Assist in Patients Recovering Spontaneous Breathing After Acute Lung Injury
A study testing PSV - pressure suppot ventilation, NAVA - Neurally Adjusted Ventilatory Assist and NAVA - EMG in people with Acute Lung Injury and Mechanical Ventilation, run by University Hospital, Caen at 1 site in France.
Trial summary
Evaluation of a new ventilatory mode Neurally Adjusted Ventilatory Assist "NAVA" in patients who recover spontaneous breathing after acute lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Mechanical Ventilation
- What is being tested?
- PSV - pressure suppot ventilation, NAVA - Neurally Adjusted Ventilatory Assist and NAVA - EMG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Hospitalized in intensive care unit
- Acute Lung Injury
- Intubated or tracheotomized and mechanically ventilated
Who cannot join
- Hemodynamic instability
- Absence of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
- Conditions
- Acute Lung Injury, Mechanical Ventilation
- Being tested
- PSV - pressure suppot ventilation, NAVA - Neurally Adjusted Ventilatory Assist, NAVA - EMG
- Keywords
- NAVA, Acute Lung Injury, Pressure Support Ventilation, Intubation, Tracheostomy, Mechanical ventilation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSV - pressure suppot ventilationDevice
Also called PSV
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 - Neurally Adjusted Ventilatory AssistDevice
Also called NAVA - Flow
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 - EMGDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Pressure Support ventilation | Active comparator | Not described Receives: Device: PSV - pressure suppot ventilation |
| NAVA flow triggering | Experimental | Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering Receives: Device: NAVA - Neurally Adjusted Ventilatory Assist |
| NAVA EMG triggering | Experimental | Spontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram Receives: Device: NAVA - EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Measured: 24 hours
Secondary outcomes (1)
Subject-ventilator synchrony
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas TERZI, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963066
- Sponsor's protocol ID
- 2009-A00583-54
- Status last verified
- Mar 2010
- First submitted
- 12 Aug 2009
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00963066
- Acronym / sponsor ID
- 2009-A00583-54
- Conditions
- Acute Lung Injury, Mechanical Ventilation
- Keywords
- NAVA, Acute Lung Injury, Pressure Support Ventilation, Intubation, Tracheostomy, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pressure Support ventilation | Active comparator | Device: PSV - pressure suppot ventilation |
| NAVA flow triggering | Experimental | Device: NAVA - Neurally Adjusted Ventilatory AssistSpontaneous Breathing using Neurally Adjusted Ventilatory Assist with flow triggering |
| NAVA EMG triggering | Experimental | Device: NAVA - EMGSpontaneous Breathing using Neurally Adjusted Ventilatory Assist with trigger adjusted on diaphragmatic electromyogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Hospitalized in intensive care unit
- Acute Lung Injury
- Intubated or tracheotomized and mechanically ventilated
Key exclusion criteria (2 listed)
- Hemodynamic instability
- Absence of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSV - pressure suppot ventilationAlso: PSVGold 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. | Device | Pressure Support ventilation |
| NAVA - Neurally Adjusted Ventilatory AssistAlso: NAVA - FlowPartial 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. | Device | NAVA flow triggering |
| NAVA - EMGPartial 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). | Device | NAVA EMG triggering |
Primary outcome
Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Time frame: 24 hours
1 secondary outcome
Subject-ventilator synchrony
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas TERZI, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSV - pressure suppot ventilation, NAVA - Neurally Adjusted Ventilatory Assist and NAVA - EMG in people with Acute Lung Injury and Mechanical Ventilation, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of physiologic response to varying levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.