Respiratory FailureNCT02499276
Comparative Effects of Variable Pressure Support, NAVA and PAV
A study testing PSV, NAVA, PAV, Variable-PSV in people with Respiratory Failure, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
Trial summary
Experimental animal data suggest that increasing breathing pattern variability in mechanical ventilation could be beneficial. Variable ventilation can be induced through the following modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and Variable-Pressure Support Ventilation… 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?
- PSV, NAVA, PAV, Variable-PSV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Dec 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
- patient on mechanical ventilation for >48 h
- estimated duration of mechanical ventilation >24h
- hemodynamic stability
Who cannot join
- pregnancy
- impossibility to insert an EAdi catheter
- neuromuscular disease, phrenic nerve lesions
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pneumologie et Réanimation Médicale, Groupe Hospitalier Pitié Salpêtrière
Paris, 75013
About this study
Official title: Comparative Effects of Variable Pressure Support, Neurally Adjusted Ventilatory Assist (NAVA) and Proportional Assist Ventilation (PAV) on the Variability of the Breathing Pattern and on Patient Ventilator Interaction
Experimental animal data suggest that increasing breathing pattern variability in mechanical ventilation could be beneficial. Variable ventilation can be induced through the following modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to each other. Pilot observations in our department suggest a feasibility in patients.
The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the variability of the breathing pattern, patient-ventilator asynchrony, risk of lung overdistension, gas exchange, and repartition of ventilation.
Read the detailed description
Cross-over, prospective, randomized controlled monocentric trial . Patients on pressure support ventilation will be ventilated with PSV, NAVA, PAV, and V-PSV (in a randomized sequence).
In each mode the level of assistance will be set to achieve a similar tidal volume of 6-8 ml/kg.
The following data will be measured and recorded: airway flow and pressure, electrical activity of the diaphragm (EAdi), blood gases, electrical impedance tomography, end tidal partial pressure in carbon dioxide (PEtCO2).
Will be calculated: the coefficient of variation (CV, standard deviation (SD)/mean) of the peak pressure (Ppeak), EAdi and of the main descriptors of the breathing pattern, the prevalence of the main patient-ventilator asynchronies, the prevalence of tidal volume (VT) >10ml/kg, ventrodorsal repartition of ventilation and inhomogeneity index, dead space
- Conditions
- Respiratory Failure
- Being tested
- PSV, NAVA, PAV, Variable-PSV
- Keywords
- mechanical ventilation, pressure support ventilation, NAVA, PAV, variable ventilation, patient ventilator asynchrony
- Medical subject headings
- Respiratory Insufficiency, Patient-Ventilator Asynchrony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSV, NAVA, PAV, Variable-PSVDevice
Each patient enrolled in the study will be ventilated in all the following modes: PSV, NAVA, PAV and variable PSV
| Study group | Role | What they receive |
|---|---|---|
| PSV, PAV, NAVA, Variable-PSV | Experimental | This is a crossover study in which each patient will be ventilated in the following modes of mechanical ventilation: Pressure Support Ventilation (PSV), Neurally Adjusted Ventilator Assist (NAVA), Proportional assist ventilation (NAVA) and variable Pressure Support Ventilation (Variable-PSV), in a randomised order. Receives: Device: PSV, NAVA, PAV, Variable-PSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation of the tidal volume (VT)
Coefficient of variation (standard deviation/mean) of the tidal volume (VT)
Measured: 1 hour
Coefficient of variation of the respiratory rate (RR)
Coefficient of variation (standard deviation/mean) of the respiratory rate (RR)
Measured: 1 hour
Coefficient of variation of the inspiratory time (Ti)
Coefficient of variation (standard deviation/mean) of the inspiratory time (Ti)
Measured: 1 hour
Coefficient of variation of the electrical activity of the diaphragm (EAdi)
Coefficient of variation (standard deviation/mean) of the electrical activity of the diaphragm (EAdi)
Measured: 1 hour
Coefficient of variation of the maximal inspiratory pressure (Ppeak)
Coefficient of variation (standard deviation/mean) of the maximal inspiratory pressure (Ppeak)
Measured: 1 hour
Secondary outcomes (5)
Patient ventilator asynchrony
asynchrony index (composite outcome, that includes double triggering, auto triggering and ineffective efforts) )
Measured: 1 hour
Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg
Measured: 1 hour
Gas exchanges
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), arterial carbon dioxide pressure (PaCO2)
Measured: 6 hours
Repartition of ventilation measured by electrical impedance tomography
Measured: 6 hours
Dead space to tidal volume ratio (Vd/Vt)
Vd/Vd, is a ratio between two volumes
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Demoule, MD, PHD, Study director, Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499276
- Sponsor's protocol ID
- ADOREPS-2013-0802
- Status last verified
- Jul 2015
- First submitted
- 12 Jun 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Variable Pressure Support, Neurally Adjusted Ventilatory Assist (NAVA) and Proportional Assist Ventilation (PAV) on the Variability of the Breathing Pattern and on Patient Ventilator Interaction
- ClinicalTrials.gov ID
- NCT02499276
- Acronym / sponsor ID
- ADOREPS-2013-0802
- Conditions
- Respiratory Failure
- Keywords
- mechanical ventilation, pressure support ventilation, NAVA, PAV, variable ventilation, patient ventilator asynchrony
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Jul 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.
Experimental animal data suggest that increasing breathing pattern variability in mechanical ventilation could be beneficial. Variable ventilation can be induced through the following modes: Neurally Adjust Ventilatory Assist (NAVA), Proportional Assist Ventilation (PAV) and Variable-Pressure Support Ventilation (V-PSV). These modes have not yet been compared to each other. Pilot observations in our department suggest a feasibility in patients.
The objectives of the study are to compare the impact of PSV, NAVA, PAV and V-PSV on the variability of the breathing pattern, patient-ventilator asynchrony, risk of lung overdistension, gas exchange, and repartition of ventilation.
Detailed description
Cross-over, prospective, randomized controlled monocentric trial . Patients on pressure support ventilation will be ventilated with PSV, NAVA, PAV, and V-PSV (in a randomized sequence).
In each mode the level of assistance will be set to achieve a similar tidal volume of 6-8 ml/kg.
The following data will be measured and recorded: airway flow and pressure, electrical activity of the diaphragm (EAdi), blood gases, electrical impedance tomography, end tidal partial pressure in carbon dioxide (PEtCO2).
Will be calculated: the coefficient of variation (CV, standard deviation (SD)/mean) of the peak pressure (Ppeak), EAdi and of the main descriptors of the breathing pattern, the prevalence of the main patient-ventilator asynchronies, the prevalence of tidal volume (VT) >10ml/kg, ventrodorsal repartition of ventilation and inhomogeneity index, dead space
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSV, PAV, NAVA, Variable-PSV | Experimental | Device: PSV, NAVA, PAV, Variable-PSVThis is a crossover study in which each patient will be ventilated in the following modes of mechanical ventilation: Pressure Support Ventilation (PSV), Neurally Adjusted Ventilator Assist (NAVA), Proportional assist ventilation (NAVA) and variable Pressure Support Ventilation (Variable-PSV), in a randomised order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient on mechanical ventilation for >48 h
- estimated duration of mechanical ventilation >24h
- hemodynamic stability
Key exclusion criteria (3 listed)
- pregnancy
- impossibility to insert an EAdi catheter
- neuromuscular disease, phrenic nerve lesions
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, NAVA, PAV, Variable-PSVEach patient enrolled in the study will be ventilated in all the following modes: PSV, NAVA, PAV and variable PSV | Device | PSV, PAV, NAVA, Variable-PSV |
Primary outcome
Coefficient of variation of the tidal volume (VT)
Time frame: 1 hour
Coefficient of variation (standard deviation/mean) of the tidal volume (VT)
Coefficient of variation of the respiratory rate (RR)
Time frame: 1 hour
Coefficient of variation (standard deviation/mean) of the respiratory rate (RR)
Coefficient of variation of the inspiratory time (Ti)
Time frame: 1 hour
Coefficient of variation (standard deviation/mean) of the inspiratory time (Ti)
Coefficient of variation of the electrical activity of the diaphragm (EAdi)
Time frame: 1 hour
Coefficient of variation (standard deviation/mean) of the electrical activity of the diaphragm (EAdi)
Coefficient of variation of the maximal inspiratory pressure (Ppeak)
Time frame: 1 hour
Coefficient of variation (standard deviation/mean) of the maximal inspiratory pressure (Ppeak)
5 secondary outcomes
Patient ventilator asynchrony
Time frame: 1 hour
Safety from lung overdistension, assessed by the proportion of tidal volumes (VT) >10 ml/kg
Time frame: 1 hour
Gas exchanges
Time frame: 6 hours
Repartition of ventilation measured by electrical impedance tomography
Time frame: 6 hours
Dead space to tidal volume ratio (Vd/Vt)
Time frame: 6 hours
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 29 Dec 2015.
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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.
Alexandre Demoule, MD, PHD study director
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
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, NAVA, PAV, Variable-PSV in people with Respiratory Failure, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil 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 3 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 29 Dec 2015. 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?
Coefficient of variation of the tidal volume (VT) (time frame: 1 hour). The study lists 5 primary outcomes in all. 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 29 Dec 2015.