Respiratory InsufficiencyPhase 1NCT01426178
Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
A Phase 1 study testing Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device) in people with Respiratory Insufficiency, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support (PSV) mode. The purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of NAVA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Jan 2012
- Phase
- Phase 1
- 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
- - Patient older then 18 years
- Patient requiring first non invasive ventilation set because of acute respiratory failure
Who cannot join
- Patients protected by the law
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support (PSV) mode.
The purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of NAVA.
Read the detailed description
After written information and consent, patients are randomised in two groups: NAVA first or PSV first.
They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter.
A standardised set of 1 hour of non-invasive ventilation is started. Depending on the randomisation group, patients start with a 30 minutes set of NIV with NAVA settings or with a 30 minutes set of NIV with PSV settings. A 30-minute watch-out period is then delivered with no mechanical ventilation.
Then a second 30-minute set of NIV in the other settings (NAVA or PSV depending on the randomisation) is delivered.
During each set of NIV, flow, volume, pressure and EADi are recorded during 10 minutes, after a 10-minute period of equilibration. Recordings will be processed by two blind investigators in order to count the number of asynchronies. In case of disagreement between investigators, a third one will be interviewed.
- Conditions
- Respiratory Insufficiency
- Being tested
- Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)
- Keywords
- Respiratory Insufficiency, Respiration, Artificial, Intermittent Positive-Pressure Ventilation, Neurally Adjusted Ventilatory Assist, Non Invasive Ventilation
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)Device
After written information and consent, patients are randomised in two groups: NAVA first or PSV first.
They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter.
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony rate defined as a percentage of the total respiratory rate
Measured: at 90 minutes
Secondary outcomes (3)
- Number of patients presenting a high asynchrony rate (>10%)
Measured: at 90 minutes
Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set
Measured: at 90 minutes
Patient comfort
Measured: at 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel CONSTANTIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426178
- Sponsor's protocol ID
- CHU-0099
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2011
- Last updated
- 5 Aug 2026
- Results posted
- No
Publications
Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.
PubMed 22661448
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
- ClinicalTrials.gov ID
- NCT01426178
- Acronym / sponsor ID
- CHU-0099
- Conditions
- Respiratory Insufficiency
- Keywords
- Respiratory Insufficiency, Respiration, Artificial, Intermittent Positive-Pressure Ventilation, Neurally Adjusted Ventilatory Assist, Non Invasive Ventilation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Aug 2011 (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.
Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support (PSV) mode.
The purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of NAVA.
Detailed description
After written information and consent, patients are randomised in two groups: NAVA first or PSV first.
They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter.
A standardised set of 1 hour of non-invasive ventilation is started. Depending on the randomisation group, patients start with a 30 minutes set of NIV with NAVA settings or with a 30 minutes set of NIV with PSV settings. A 30-minute watch-out period is then delivered with no mechanical ventilation.
Then a second 30-minute set of NIV in the other settings (NAVA or PSV depending on the randomisation) is delivered.
During each set of NIV, flow, volume, pressure and EADi are recorded during 10 minutes, after a 10-minute period of equilibration. Recordings will be processed by two blind investigators in order to count the number of asynchronies. In case of disagreement between investigators, a third one will be interviewed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Patient older then 18 years
- Patient requiring first non invasive ventilation set because of acute respiratory failure
Key exclusion criteria (2 listed)
- Patients protected by the law
- Pregnant women
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 |
|---|---|---|
| Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)After written information and consent, patients are randomised in two groups: NAVA first or PSV first. They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter. | Device | – |
Primary outcome
Asynchrony rate defined as a percentage of the total respiratory rate
Time frame: at 90 minutes
3 secondary outcomes
- Number of patients presenting a high asynchrony rate (>10%)
Time frame: at 90 minutes
Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set
Time frame: at 90 minutes
Patient comfort
Time frame: at 90 minutes
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 5 Aug 2026.
- Results publication: PubMed 22661448Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.
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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.
Jean-Michel CONSTANTIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device) in people with Respiratory Insufficiency, run by University Hospital, Clermont-Ferrand 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 2 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 5 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Asynchrony rate defined as a percentage of the total respiratory rate (time frame: at 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01426178, which also lists 1 linked publication.
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 5 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.