Acute Respiratory FailureNCT02133443
NAVASET: Nava Level Titration Using Comfort Scales
A study testing PSV - pressure support ventilation and Neurally Adjusted Ventilatory Assist in people with Acute Respiratory Failure, run by University Hospital, Caen at 1 site in France.
Trial summary
Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains challenging, and several methods have been suggested. However none of them seems easily utilisable. Thus the investigators propose to test a way of NAVA level titration according to ventilator comfort. 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 - pressure support ventilation and Neurally Adjusted Ventilatory Assist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 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
- Age > 18 years
- Hospitalized in intensive care unit for an acute respiratory failure
- Intubated or tracheotomized and mechanically ventilated
- RASS score: 0;-2
- Weaning period
Who cannot join
- Hemodynamic instability
- Absence of consent
- Contraindication of nasogastric catheter insertion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Caen
Caen, 14000
Nicolas TERZI, MD-PhD, +33231064716, terzi-n@chu-caen.fr
Nicolas TERZI, MD-PhD
About this study
Official title: Neurally Adjusted Ventilatory Assist (NAVA) Levels Titration During Weaning Using Ventilatory Comfort Scales: a Physiological Evaluation
Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains challenging, and several methods have been suggested. However none of them seems easily utilisable. Thus the investigators propose to test a way of NAVA level titration according to ventilator comfort.
Read the detailed description
Physiological comparison of different levels of ventilator assistance during Neurally Adjusted Ventilatory Assist (NAVA) to evaluate the effect of these on tidal volume, inspiratoy activity, comfort scales.
We propose to evaluate the ability to guide the titration according the patient's comfort scale. The intensity of the breathing sensations will be evaluated using the labeled visual analog scale (Banzett Scale).
- Conditions
- Acute Respiratory Failure
- Being tested
- PSV - pressure support ventilation, Neurally Adjusted Ventilatory Assist
- Keywords
- Mechanical ventilation, Acute respiratory failure, Weaning, Pressure support ventilation, Neurally adjusted ventilatory assist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSV - pressure support ventilationDevice
Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Pressure support ventilator assistance to obtain a tidal volume of 6-8 ml/kg of ideal body weight.
Neurally Adjusted Ventilatory AssistDevice
Partial ventilator support partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Stepwise implementation of the NAVA level (steps of 25% ), returning to the " optimal " level between each evaluation (PSV 100%, NAVA 100%, 75%, 50%, 125%, 150%).
| Study group | Role | What they receive |
|---|---|---|
| Pressure Support Ventilation | Active comparator | Device: PSV - pressure support ventilation Receives: Device: PSV - pressure support ventilation |
| Neurally Adjusted Ventilatory Assist | Active comparator | Device: Partial ventilator support with partial ventilation mode (NAVA) Receives: Device: Neurally Adjusted Ventilatory Assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ventilatory comfort with the physiological parameters when varying the levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
To prove the feasibility of neurally adjusted ventilatory assist (NAVA) level titration according to the ventilatory comfort felt by the patient. The ventilatory comfort will be evaluated using the labeled visual analog scale (Banzett scale).
Measured: 24hr
Secondary outcomes (2)
Efficiency
The efficiency will be evaluated by using minute ventilation
Measured: 24hr
Efficiency
The efficiency will be evaluated using arterial PCO2.
Measured: 24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre d'Investigation Clinique et Technologique 805
- Responsible party
- Principal investigator, Nicolas TERZI, University Hospital, Caen
- Investigators
- Nicolas TERZI, MD-PhD, Principal investigator, University Hospital, CaenFrédéric Lofaso, MD-PhD, Principal investigator, University Hospital, Garches
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133443
- Sponsor's protocol ID
- 2013-A01835-40
- Other IDs
- 2013-A01835-40
- Status last verified
- May 2014
- First submitted
- 30 Apr 2014
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Adjusted Ventilatory Assist (NAVA) Levels Titration During Weaning Using Ventilatory Comfort Scales: a Physiological Evaluation
- ClinicalTrials.gov ID
- NCT02133443
- Acronym / sponsor ID
- 2013-A01835-40
- Conditions
- Acute Respiratory Failure
- Keywords
- Mechanical ventilation, Acute respiratory failure, Weaning, Pressure support ventilation, Neurally adjusted ventilatory assist
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Centre d'Investigation Clinique et Technologique 805
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 8 May 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.
Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains challenging, and several methods have been suggested. However none of them seems easily utilisable. Thus the investigators propose to test a way of NAVA level titration according to ventilator comfort.
Detailed description
Physiological comparison of different levels of ventilator assistance during Neurally Adjusted Ventilatory Assist (NAVA) to evaluate the effect of these on tidal volume, inspiratoy activity, comfort scales.
We propose to evaluate the ability to guide the titration according the patient's comfort scale. The intensity of the breathing sensations will be evaluated using the labeled visual analog scale (Banzett Scale).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure Support Ventilation | Active comparator | Device: PSV - pressure support ventilationDevice: PSV - pressure support ventilation |
| Neurally Adjusted Ventilatory Assist | Active comparator | Device: Neurally Adjusted Ventilatory AssistDevice: Partial ventilator support with partial ventilation mode (NAVA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Hospitalized in intensive care unit for an acute respiratory failure
- Intubated or tracheotomized and mechanically ventilated
- RASS score: 0;-2
- Weaning period
Key exclusion criteria (3 listed)
- Hemodynamic instability
- Absence of consent
- Contraindication of nasogastric catheter insertion
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 - pressure support ventilationGold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Pressure support ventilator assistance to obtain a tidal volume of 6-8 ml/kg of ideal body weight. | Device | Pressure Support Ventilation |
| Neurally Adjusted Ventilatory AssistPartial ventilator support partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Stepwise implementation of the NAVA level (steps of 25% ), returning to the " optimal " level between each evaluation (PSV 100%, NAVA 100%, 75%, 50%, 125%, 150%). | Device | Neurally Adjusted Ventilatory Assist |
Primary outcome
Comparison of ventilatory comfort with the physiological parameters when varying the levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
Time frame: 24hr
To prove the feasibility of neurally adjusted ventilatory assist (NAVA) level titration according to the ventilatory comfort felt by the patient. The ventilatory comfort will be evaluated using the labeled visual analog scale (Banzett scale).
2 secondary outcomes
Efficiency
Time frame: 24hr
Efficiency
Time frame: 24hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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.
Nicolas TERZI, MD-PhD principal investigator
University Hospital, Caen
Frédéric Lofaso, MD-PhD principal investigator
University Hospital, Garches
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 - pressure support ventilation and Neurally Adjusted Ventilatory Assist in people with Acute Respiratory Failure, run by University Hospital, Caen 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 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: status not confirmed, as of the sponsor's last update on 8 May 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?
Comparison of ventilatory comfort with the physiological parameters when varying the levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA) (time frame: 24hr). 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 8 May 2014.