Acute Respiratory DistressNAVA-VNINCT01928238
Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive Pressure Support Ventilation in Patients at Risk for Respiratory Distress Needed Preventive Used of Noninvasive Ventilation After Extubation.
A study testing Noninvasive neurally adjusted ventilatory assist (NIV-NAVA). and Noninvasive pressure support ventilation (NPSV) in people with Acute Respiratory Distress, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in patient at risk of respiratory distress after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress
- What is being tested?
- Noninvasive neurally adjusted ventilatory assist (NIV-NAVA). and Noninvasive pressure support ventilation (NPSV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to Jan 2015
- 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
- Patients intubated for 48 h or more
- Patients who tolerated a 120-min spontaneous breathing trial after recovery from their acute disease with no signs of respiratory failure
- Patients at high risk for respiratory after extubation were enrolled if they had at least two of the following risk factors for respiratory failure after extubation:
- age older than 65 years
- Chronic obstructive pulmonary disease,
- heart failure as the cause for intubation
- An Acute Physiology and Chronic Health Evaluation (APACHE)-II score greater than 12 on the day of extubation.
Who cannot join
- Age younger than 18 years
- Head trauma or surgery
- Recent gastric or oesophageal surgery
- Active upper gastrointestinal bleeding
- Excessive amount of respiratory secretions
- Poor cooperation
Show all 10Show fewer
- Decision to limit life-supporting treatments in the ICU
- Tracheostomy or other upper airway disorders
- Lack of collaboration
- Do not resuscitate order or any decision to limit therapeutic effort in the ICU.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in patient at risk of respiratory distress after extubation.
Read the detailed description
Reintubation, which occurs after planned extubation, is a relevant consequence of respiratory failure after extubation. The early use of noninvasive pressure support ventilation averted respiratory failure after extubation in patients at increased risk. However patient tolerance to the technique is a critical factor determining its success. One of the key factors determining tolerance to Non Invasive Ventilation (NIV) is optimal synchrony between the patient's spontaneous breathing activity and the ventilator's settings, known as patient ventilator interaction. Optimal patient-ventilator synchrony during NIV can prove very difficult to achieve due to the presence of leaks, the type of interface which can interfere with various aspects of ventilator function. Patient ventilator synchrony during NPSV can be compromised when using conventional pneumatic triggering, with the ventilator-delivered inspiratory support starting after the patient's inspiratory effort. The switch from inspiration to expiration (cycling-off) should, ideally, coincide with the end of the patient's inspiratory effort. However greater asynchrony at the end of inspiration, with the ventilator cycling off either too early or too late compared to the end of the patient's inspiratory effort can be observed during NPSV. A possible solution is to replace the pneumatic triggering with neural triggering and cycling off using the diaphragm electrical activity (Eadi). Neurally adjusted ventilatory assist (NAVA) uses the electrical activity of the diaphragm to control the timing and pressure of the ventilation delivered. The ventilator is triggered, limited and cycled-off directly by Eadi. The Eadi is measured by a multiple array oesophageal electrode. The array of bipolar electrodes can be mounted on a feeding tube, which is routinely introduced in critically ill patients.
- Conditions
- Acute Respiratory Distress
- Being tested
- Noninvasive neurally adjusted ventilatory assist (NIV-NAVA)., Noninvasive pressure support ventilation (NPSV)
- Keywords
- NIV, NAVA, noninvasive neurally adjusted ventilatory, noninvasive pressure support 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.
Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).Device
Noninvasive pressure support ventilation (NPSV)Device
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients will have two 20-minute noninvasive periods :
Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) and then Noninvasive pressure support ventilation (NPSV) Receives: Device: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).; Device: Noninvasive pressure support ventilation (NPSV) |
| Arm 2 | Experimental | Patients will have two 20-minute noninvasive periods :
Noninvasive pressure support ventilation (NPSV) and then Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) Receives: Device: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).; Device: Noninvasive pressure support ventilation (NPSV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory muscle effort
The primary endpoint variable is the inspiratory muscle effort. To estimate the inspiratory effort, we will determine the transdiaphragmatic pressure (Pdi), the transdiaphragmatic pressure time product per breath (PTPdi/b) or per minute (PTPdi/min) and the Electrical Activity of the Diaphragm (EADI)max.
Measured: At inclusion (day 0)
Secondary outcomes (3)
patient ventilator synchrony
Patient ventilator synchrony will be identified by estimating the following variables: autocycled breaths, ineffective inspiratory effort, the inspiratory trigger delay, the expiratory trigger delay and the time of synchrony between muscle effort and ventilator support.
Measured: At inclusion (Day 0)
gas exchange
Measured: At inclusion (Day 0)
Patient comfort
Patient comfort will be assessed using a five-item semi quantitative scale: 1, uncomfortable; 2, somewhat uncomfortable; 3, acceptable; 4, somewhat comfortable; and 5, comfortable.
Measured: At inclusion (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory DistressStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric VARGAS, MD-PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928238
- Sponsor's protocol ID
- CHUBX 2011/27
- Other IDs
- 2012-A00197-36
- Acronym
- NAVA-VNI
- Status last verified
- Jan 2015
- First submitted
- 20 Aug 2013
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Effects of Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) Versus Noninvasive Pressure Support Ventilation in Patients at Risk for Respiratory Distress Needed Preventive Used of Noninvasive Ventilation After Extubation.
- ClinicalTrials.gov ID
- NCT01928238
- Acronym / sponsor ID
- NAVA-VNI / CHUBX 2011/27
- Conditions
- Acute Respiratory Distress
- Keywords
- NIV, NAVA, noninvasive neurally adjusted ventilatory, noninvasive pressure support ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Aug 2013 (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.
The purpose of this study is to compare inspiratory effort, comfort, gas exchange and patient ventilator synchrony during non-invasive neurally adjusted ventilatory assist or pneumatically triggered and cycled-off noninvasive pressure support ventilation (NPSV), in patient at risk of respiratory distress after extubation.
Detailed description
Reintubation, which occurs after planned extubation, is a relevant consequence of respiratory failure after extubation. The early use of noninvasive pressure support ventilation averted respiratory failure after extubation in patients at increased risk. However patient tolerance to the technique is a critical factor determining its success. One of the key factors determining tolerance to Non Invasive Ventilation (NIV) is optimal synchrony between the patient's spontaneous breathing activity and the ventilator's settings, known as patient ventilator interaction. Optimal patient-ventilator synchrony during NIV can prove very difficult to achieve due to the presence of leaks, the type of interface which can interfere with various aspects of ventilator function. Patient ventilator synchrony during NPSV can be compromised when using conventional pneumatic triggering, with the ventilator-delivered inspiratory support starting after the patient's inspiratory effort. The switch from inspiration to expiration (cycling-off) should, ideally, coincide with the end of the patient's inspiratory effort. However greater asynchrony at the end of inspiration, with the ventilator cycling off either too early or too late compared to the end of the patient's inspiratory effort can be observed during NPSV. A possible solution is to replace the pneumatic triggering with neural triggering and cycling off using the diaphragm electrical activity (Eadi). Neurally adjusted ventilatory assist (NAVA) uses the electrical activity of the diaphragm to control the timing and pressure of the ventilation delivered. The ventilator is triggered, limited and cycled-off directly by Eadi. The Eadi is measured by a multiple array oesophageal electrode. The array of bipolar electrodes can be mounted on a feeding tube, which is routinely introduced in critically ill patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA)., Device: Noninvasive pressure support ventilation (NPSV)Patients will have two 20-minute noninvasive periods : Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) and then Noninvasive pressure support ventilation (NPSV) |
| Arm 2 | Experimental | Device: Noninvasive neurally adjusted ventilatory assist (NIV-NAVA)., Device: Noninvasive pressure support ventilation (NPSV)Patients will have two 20-minute noninvasive periods : Noninvasive pressure support ventilation (NPSV) and then Noninvasive neurally adjusted ventilatory assist (NIV-NAVA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients intubated for 48 h or more
- Patients who tolerated a 120-min spontaneous breathing trial after recovery from their acute disease with no signs of respiratory failure
- Patients at high risk for respiratory after extubation were enrolled if they had at least two of the following risk factors for respiratory failure after extubation:
Key exclusion criteria (10 listed)
- Age younger than 18 years
- Head trauma or surgery
- Recent gastric or oesophageal surgery
- Active upper gastrointestinal bleeding
- Excessive amount of respiratory secretions
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 |
|---|---|---|
| Noninvasive neurally adjusted ventilatory assist (NIV-NAVA). | Device | Arm 1, Arm 2 |
| Noninvasive pressure support ventilation (NPSV) | Device | Arm 1, Arm 2 |
Primary outcome
Inspiratory muscle effort
Time frame: At inclusion (day 0)
The primary endpoint variable is the inspiratory muscle effort. To estimate the inspiratory effort, we will determine the transdiaphragmatic pressure (Pdi), the transdiaphragmatic pressure time product per breath (PTPdi/b) or per minute (PTPdi/min) and the Electrical Activity of the Diaphragm (EADI)max.
3 secondary outcomes
patient ventilator synchrony
Time frame: At inclusion (Day 0)
gas exchange
Time frame: At inclusion (Day 0)
Patient comfort
Time frame: At inclusion (Day 0)
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 22 May 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.
Frédéric VARGAS, MD-PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive neurally adjusted ventilatory assist (NIV-NAVA). and Noninvasive pressure support ventilation (NPSV) in people with Acute Respiratory Distress, run by University Hospital, Bordeaux 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 7 inclusion and 10 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 22 May 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?
Inspiratory muscle effort (time frame: At inclusion (day 0)). 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 22 May 2026.