Respiratory FailureSENANCT02382861
Conventional vs Neurally Adjusted Ventilatory Assist in Difficult Weaning From Mechanical Ventilation
A study testing Neurally adjusted ventilatory assist and Noninvasive pressure support ventilation in people with Respiratory Failure, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Neurally adjusted ventilatory assist and Noninvasive pressure support ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2015to Jan 2017
- 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
- Under mechanical ventilation > 48 hours
- A first failure of a SBT
- Plateau pressure 30cmH2O with tidal volume 8ml / kg
- SpO2 ≥ in 90 % with a FiO2 ≥ 50 %, or PaO2 / FiO2 > 150mmHg
- Positive expiratory pressure 8cmH2O
Show all 10Show fewer
- No more of one mg/hour of noradrenaline or adrenalin
- Temperature >36 and <39°C.
- Stable neurological state (Glasgow scale > 4) without sedation (or very low sedation).
- Consent, dated and signed by the patient or his representative.
Who cannot join
- Contraindications to the NAVA (recent high digestive suture or oesophageal varices bleeding < 4 days).
- Pregnant woman.
- Age <18 years.
- Tracheotomy.
- Cardiac arrest with a reserved neurological prognostic.
- Therapeutic limitation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized and Controlled Study Estimating the Neurally Adjusted Ventilatory Assist (NAVA) Versus the Pressure Support Ventilatory (PSV) in Difficult Weaning From Mechanical Ventilation
The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.
Read the detailed description
- Background: The NAVA is a new mode of ventilation which works from the continuous recording of the electromyogram of the diaphragm. In theory, the NAVA delivred a proportional and synchronous assistance, to respiratory efforts allowing a more adequate ventilatory support. However, no study estimates the NAVA in the weaning from mechanical ventilation.
- Purpose: The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.
- Detailed description: Approximately 20 to 25 % of the patients under mechanical ventilation who have the general criteria of weaning will not pass a first SBT (Spontaneous Breathing Trial). At this moment, the management of the weaning ventilatoire are made with PSV. The NAVA is proportional assistance and depends on the intensity of the electric diaphragmatic signal (Edi). The respiratory effort of the patient is directly detected from the Edi signal. In theory, the NAVA is a proportional and synchronous respiratory.
- After a first failure of a SBT, patients respecting the inclusion criteria and exlusion criteria described above are then included in the study and randomized in two groups (control group or NAVA group).
- In the control group, the PSV is decreased of 2cmH2O daily or several times a day to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
- In the NAVA group, the level of NAVA is daily adjusted to obtain Eadimax corresponding to 60 % of Eadimax of the patient during the SBT to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
- Twice a day, the criteria of SBT are looked for. When they are present, a SBT is realized. If it is a success, the patient will be extube. If it is a failure, the patient will be reventilated in PSV or NAVA according to their group. A non-invasive ventilation preventive or of "rescue" can be administered post-extubation according to criteria. The reintubated criteria are also defined.
- Conditions
- Respiratory Failure
- Being tested
- Neurally adjusted ventilatory assist, Noninvasive pressure support ventilation
- Keywords
- Neurally adjusted ventilatory assist, Weaning, Mechanical ventilation, Extubation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally adjusted ventilatory assistDevice
In the NAVA group, the level of NAVA is daily adjusted to obtain Eadimax corresponding to 60 % of Eadimax of the patient during the SBT to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
Noninvasive pressure support ventilationDevice
In the control group, the PSV is decreased of 2cmH2O daily or several times a day to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
| Study group | Role | What they receive |
|---|---|---|
| NAVA group | Experimental | Management of the difficult weaning from mechanical ventilation by the NAVA. Receives: Device: Neurally adjusted ventilatory assist |
| Control group | Active comparator | Conventional management of the difficult weaning from mechanical ventilation, with the pressure ventilation. Receives: Device: Noninvasive pressure support ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of weaning from the mechanical invasive ventilation.
This duration is defined by the period between the first failure of the spontaneous breathing trial (SBT) and 48 hours after the extubation.
Measured: 48 hours after the extubation
Secondary outcomes (7)
Duration between the inclusion and the success of the SBT
Measured: 28th day
Duration of invasive mechanical ventilation
Measured: 28th day
Rate of failure of SBT
Measured: 28th day
Rate of success of SBT
Measured: 28th day
Rate of ventilator-associated pneumonia
Measured: 28th day
Length of intensive care unit stay
Measured: 28th day
Duration of hospitalization
Measured: 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start20 Feb 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul PEREZ, Doctor, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382861
- Sponsor's protocol ID
- CHUBX 2012/12
- Other IDs
- 2013-A00717-38
- Acronym
- SENA
- Status last verified
- Oct 2018
- First submitted
- 3 Mar 2015
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Prospective, Randomized and Controlled Study Estimating the Neurally Adjusted Ventilatory Assist (NAVA) Versus the Pressure Support Ventilatory (PSV) in Difficult Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02382861
- Acronym / sponsor ID
- SENA / CHUBX 2012/12
- Conditions
- Respiratory Failure
- Keywords
- Neurally adjusted ventilatory assist, Weaning, Mechanical ventilation, Extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Mar 2015 (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 NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.
Detailed description
- Background: The NAVA is a new mode of ventilation which works from the continuous recording of the electromyogram of the diaphragm. In theory, the NAVA delivred a proportional and synchronous assistance, to respiratory efforts allowing a more adequate ventilatory support. However, no study estimates the NAVA in the weaning from mechanical ventilation.
- Purpose: The NAVA, by its more physiological aspect and a better adaptation of the patient to the ventilator with a decrease of asynchronies patients-ventilators, could decrease the duration of weaning and so decrease the duration of invasive mechanical ventilation and the morbi-mortality. The objective of this study is to compare the neurally adjusted ventilatory assist versus the usual management of weaning from mechanical ventilation, in term of duration of weaning, at the patients in period of difficult weaning from the invasive mechanical ventilation.
- Detailed description: Approximately 20 to 25 % of the patients under mechanical ventilation who have the general criteria of weaning will not pass a first SBT (Spontaneous Breathing Trial). At this moment, the management of the weaning ventilatoire are made with PSV. The NAVA is proportional assistance and depends on the intensity of the electric diaphragmatic signal (Edi). The respiratory effort of the patient is directly detected from the Edi signal. In theory, the NAVA is a proportional and synchronous respiratory.
- After a first failure of a SBT, patients respecting the inclusion criteria and exlusion criteria described above are then included in the study and randomized in two groups (control group or NAVA group).
- In the control group, the PSV is decreased of 2cmH2O daily or several times a day to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
- In the NAVA group, the level of NAVA is daily adjusted to obtain Eadimax corresponding to 60 % of Eadimax of the patient during the SBT to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
- Twice a day, the criteria of SBT are looked for. When they are present, a SBT is realized. If it is a success, the patient will be extube. If it is a failure, the patient will be reventilated in PSV or NAVA according to their group. A non-invasive ventilation preventive or of "rescue" can be administered post-extubation according to criteria. The reintubated criteria are also defined.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVA group | Experimental | Device: Neurally adjusted ventilatory assistManagement of the difficult weaning from mechanical ventilation by the NAVA. |
| Control group | Active comparator | Device: Noninvasive pressure support ventilationConventional management of the difficult weaning from mechanical ventilation, with the pressure ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age >18 years
- Under mechanical ventilation > 48 hours
- A first failure of a SBT
- Plateau pressure 30cmH2O with tidal volume 8ml / kg
- SpO2 ≥ in 90 % with a FiO2 ≥ 50 %, or PaO2 / FiO2 > 150mmHg
Key exclusion criteria (6 listed)
- Contraindications to the NAVA (recent high digestive suture or oesophageal varices bleeding < 4 days).
- Pregnant woman.
- Age <18 years.
- Tracheotomy.
- Cardiac arrest with a reserved neurological prognostic.
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 assistIn the NAVA group, the level of NAVA is daily adjusted to obtain Eadimax corresponding to 60 % of Eadimax of the patient during the SBT to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg. | Device | NAVA group |
| Noninvasive pressure support ventilationIn the control group, the PSV is decreased of 2cmH2O daily or several times a day to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg. | Device | Control group |
Primary outcome
Duration of weaning from the mechanical invasive ventilation.
Time frame: 48 hours after the extubation
This duration is defined by the period between the first failure of the spontaneous breathing trial (SBT) and 48 hours after the extubation.
7 secondary outcomes
Duration between the inclusion and the success of the SBT
Time frame: 28th day
Duration of invasive mechanical ventilation
Time frame: 28th day
Rate of failure of SBT
Time frame: 28th day
Rate of success of SBT
Time frame: 28th day
Rate of ventilator-associated pneumonia
Time frame: 28th day
Length of intensive care unit stay
Time frame: 28th day
Duration of hospitalization
Time frame: 28th day
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.
Paul PEREZ, Doctor study chair
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 Neurally adjusted ventilatory assist and Noninvasive pressure support ventilation in people with Respiratory Failure, 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 10 inclusion and 6 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?
Duration of weaning from the mechanical invasive ventilation. (time frame: 48 hours after the extubation). 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.