Critical IllnessPhase 3NCT01607723
"NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes
A Phase 3 study testing NAVA ventilatory mode and PAV+ ventilatory mode in people with Critical Illness and Mechanical Ventilation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Mechanical Ventilation, Intensive Care
- What is being tested?
- NAVA ventilatory mode and PAV+ ventilatory mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Mar 2014
- Phase
- Phase 3
- 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
- Estimated remaining duration of mechanical ventilation for more than two days
- patient alert and calm
- Surrogate decision maker's consent
Who cannot join
- Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
- Clinical instability for any reason
- Contraindications for continuing intensive care treatment
- Patient under tutelage
- Age < 18 years
- Pregnancy
- No French health insurance
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, 34000
About this study
Official title: Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study
Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.
Read the detailed description
Twenty patients will be enrolled. They will be ventilated with PAV+ and NAVA for one day, each in a randomized crossover order. The oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.
- Being tested
- NAVA ventilatory mode, PAV+ ventilatory mode
- Keywords
- Sleep pattern, Mechanical ventilation, weaning, Intensive Care, NAVA (Neurally Adjusted Ventilatory Assist), PAV+ (Proportional Assist Ventilation Plus)
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVA ventilatory modeOther
The two ventilatory modes will be studied during 24h in intubated patients in random order.
PAV+ ventilatory modeOther
The two ventilatory modes will be studied during 24h in intubated patients in random order.
| Study group | Role | What they receive |
|---|---|---|
| NAVA ventilatory mode | Other | Not described Receives: Other: NAVA ventilatory mode |
| PAV+ ventilatory mode | Other | Not described Receives: Other: PAV+ ventilatory mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation in NAVA and in PAV+
Measured: after one day of ventilation in NAVA and in PAV+
Secondary outcomes (4)
Ventilatory comfort
Ventilatory comfort will be assessed by :
- objective criteria expressed in time spent in each mode in the area called "comfort" (12 < Respiratory frequence < 28 c/min ; Current Volume > 300 mL and EtCO2 < 55 mmHg)
- subjective criteria expressed by the self-assessment of the patient's comfort on a visual analogic scale.
Measured: Every 6 hours in the two ventilatory modes
Patient-ventilator asynchronies
The patient-ventilator asynchronies will be assessed by the asynchronie index (number of asynchronies / number of respiratory cycles). The number of asynchronies will be assessed by the investigator, on the records of the pression curves and the respirator outputs.
Measured: During the 24h of mechanical ventilation in NAVA and in PAV+
Ventilatory parameters
The aeration and pulmonary ventilation will be assessed by electrical impedance (PulmoVista®500, Drager, Suisse).
Measured: During the 24h of mechanical ventilation in NAVA and in PAV+
Sleep pattern
Measured: During 24h of mechanical ventilation in NAVA and in PAV+
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607723
- Sponsor's protocol ID
- UF 8916
- Status last verified
- Dec 2014
- First submitted
- 18 Apr 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two New Ventilatory Modes: NAVA vs PAV+: a Randomized Controlled Cross-over Study: the "NAVA-PAV" Study
- ClinicalTrials.gov ID
- NCT01607723
- Acronym / sponsor ID
- UF 8916
- Keywords
- Sleep pattern, Mechanical ventilation, weaning, Intensive Care, NAVA (Neurally Adjusted Ventilatory Assist), PAV+ (Proportional Assist Ventilation Plus)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 May 2012 (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.
Neurally adjusted ventilatory assist (NAVA) and Proportional Assist Ventilatory Plus (PAV +) are new modes of mechanical ventilation that delivers ventilatory assist in proportion to the electrical activity of the diaphragm for NAVA and to patients efforts for PAV +. The goal of this trial is to compare oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern between NAVA and PAV+.
Detailed description
Twenty patients will be enrolled. They will be ventilated with PAV+ and NAVA for one day, each in a randomized crossover order. The oxygenation,ventilator comfort, patients -ventilator asynchronies, and sleep pattern will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAVA ventilatory mode | Other | Other: NAVA ventilatory mode |
| PAV+ ventilatory mode | Other | Other: PAV+ ventilatory mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Estimated remaining duration of mechanical ventilation for more than two days
- patient alert and calm
- Surrogate decision maker's consent
Key exclusion criteria (7 listed)
- Clinical contraindication for the use of NAVA: contraindications for an EAdi catheter placement (e.g., esophageal varices, upper gastrointestinal bleeding, gastroesophageal surgery)
- Clinical instability for any reason
- Contraindications for continuing intensive care treatment
- Patient under tutelage
- Age < 18 years
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 |
|---|---|---|
| NAVA ventilatory modeThe two ventilatory modes will be studied during 24h in intubated patients in random order. | Other | NAVA ventilatory mode |
| PAV+ ventilatory modeThe two ventilatory modes will be studied during 24h in intubated patients in random order. | Other | PAV+ ventilatory mode |
Primary outcome
Oxygenation in NAVA and in PAV+
Time frame: after one day of ventilation in NAVA and in PAV+
4 secondary outcomes
Ventilatory comfort
Time frame: Every 6 hours in the two ventilatory modes
Patient-ventilator asynchronies
Time frame: During the 24h of mechanical ventilation in NAVA and in PAV+
Ventilatory parameters
Time frame: During the 24h of mechanical ventilation in NAVA and in PAV+
Sleep pattern
Time frame: During 24h of mechanical ventilation in NAVA and in PAV+
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 3 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NAVA ventilatory mode and PAV+ ventilatory mode in people with Critical Illness and Mechanical Ventilation, run by University Hospital, Montpellier 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 3 inclusion and 7 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 3 Dec 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Oxygenation in NAVA and in PAV+ (time frame: after one day of ventilation in NAVA and in PAV+). 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 3 Dec 2014; AzTrials last refreshed its copy on 26 Oct 2026.