Acute Respiratory FailurePAVANAVANCT02056093
Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
A study testing PSV mode, PAV mode and NAVA in people with Acute Respiratory Failure, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- PSV mode, PAV mode and NAVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Feb 2014
- 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
- Intubated patients.
- Mechanical ventilation for a respiratory reason.
- Expected duration of Mechanical ventilation > 48 hrs.
- Spontaneous breathing.
- Sedations stopped for more than 24 hours.
Who cannot join
- - Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.
- Main contra indications to PAV: airway leak, body weight <25 kg, neuromuscular diseases.
- Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.
- Severe hypoxemia defined as PaO2/FiO2 ratio <200.
- Decision to withhold life-sustaining treatment.
- Pregnant women.
- Minors < 18 years.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere
Paris, Île-de-France Region, 75013
Matthieu SCHMIDT, MD, matthieuschmidt@yahoo.fr
Matthieu Schmidt, MD
About this study
Official title: Breathing Pattern Variability, Respiratory Discomfort and Work of Breathing in Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.
- Conditions
- Acute Respiratory Failure
- Being tested
- PSV mode, PAV mode, NAVA
- Keywords
- NAVA - PAV- Breathing Variability - Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSV modeDevice
Application of PSV in all patients
PAV modeDevice
Application of PAV mode in all patients
NAVADevice
| Study group | Role | What they receive |
|---|---|---|
| Intubated patients | Experimental | Intubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study. Receives: Device: PSV mode; Device: PAV mode; Device: NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing pattern variability
The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)
Measured: February 2014
Secondary outcomes (1)
Patient-ventilator asynchrony
Prevalence of ineffective efforts and double triggering (expressed as a number of events per minute)
Measured: February, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
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 Acute 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre and Marie Curie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthieu SCHMIDT, Pierre and Marie Curie University
- Investigators
- Matthieu SCHMIDT, MD, Principal investigator, Association pour le Développement et l'Organisation de la Recherche en Pneumologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056093
- Sponsor's protocol ID
- ADOREP
- Acronym
- PAVANAVA
- Status last verified
- Feb 2014
- First submitted
- 18 Dec 2013
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.
PubMed 25879592
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Pattern Variability, Respiratory Discomfort and Work of Breathing in Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist
- ClinicalTrials.gov ID
- NCT02056093
- Acronym / sponsor ID
- PAVANAVA / ADOREP
- Conditions
- Acute Respiratory Failure
- Keywords
- NAVA - PAV- Breathing Variability - Asynchrony
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 5 Feb 2014 (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.
In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated patients | Experimental | Device: PSV mode, Device: PAV mode, Device: NAVAIntubated patients: The three modes (PSV, PAV, NAVA) will be applied in random order to each mechanically ventilated patient included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intubated patients.
- Mechanical ventilation for a respiratory reason.
- Expected duration of Mechanical ventilation > 48 hrs.
- Spontaneous breathing.
- Sedations stopped for more than 24 hours.
Key exclusion criteria (7 listed)
- - Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.
- Main contra indications to PAV: airway leak, body weight <25 kg, neuromuscular diseases.
- Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.
- Severe hypoxemia defined as PaO2/FiO2 ratio <200.
- Decision to withhold life-sustaining treatment.
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 modeApplication of PSV in all patients | Device | Intubated patients |
| PAV modeApplication of PAV mode in all patients | Device | Intubated patients |
| NAVA | Device | Intubated patients |
Primary outcome
Breathing pattern variability
Time frame: February 2014
The coefficient of variation (standard deviation divided by the mean) of the tidal volume (expressed in %)
1 secondary outcome
Patient-ventilator asynchrony
Time frame: February, 2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
- Derived from this study: PubMed 25879592Schmidt M, Kindler F, Cecchini J, Poitou T, Morawiec E, Persichini R, Similowski T, Demoule A. Neurally adjusted ventilatory assist and proportional assist ventilation both improve patient-ventilator interaction. Crit Care. 2015 Feb 25;19(1):56. doi: 10.1186/s13054-015-0763-6.
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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.
Service de Pneumologie et de Reanimation médicale, Groupe hospitalier Pitie Salpetriere
Paris, France
Matthieu SCHMIDT, MD principal investigator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie
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 mode, PAV mode and NAVA in people with Acute Respiratory Failure, run by Pierre and Marie Curie University 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 5 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: status not confirmed, as of the sponsor's last update on 5 Feb 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing pattern variability (time frame: February 2014). 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 NCT02056093, 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 Feb 2014.