Non Invasive VentilationNCT01074866
Neurally Adjusted Ventilatory Assist for Non Invasive Ventilation and Patient-ventilator Interaction
A study testing Neurally Adjusted Ventilatory Assist in people with Non Invasive Ventilation and Patient Ventilator Interaction, run by University Hospital, Geneva at 4 sites in 2 countries.
Trial summary
The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non Invasive Ventilation, Patient Ventilator Interaction
- What is being tested?
- Neurally Adjusted Ventilatory Assist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2010to Dec 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the ICU and treated with Non invasive ventilation for acute respiratory failure of any origin
Who cannot join
- severe hypoxemia requiring an FIO2>0.6
- hemodynamic instability
- known oesophageal problem
- active upper gastro-intestinal bleeding
- any other contraindication to the insertion of a naso-gastric tube
- impaired consciousness or absence of patient cooperation
- facial or laryngeal lesions contraindicating the use of NIV
- poor short term prognosis
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Switzerland2 sites
HUG, University Hospital
Geneva, 1211
CHUV University hospital of Lausanne
Lausanne, 1011
About this study
Official title: The Effects of Neurally Adjusted Ventilatory Assist (NAVA) on Improving Patient-ventilator Interaction in Patients Undergoing Ventilation for Acute Respiratory Failure
The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin.
Read the detailed description
The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin. The subgroup of COPD patients will be analyzed separately. The effects of various setting of Neurally adjusted ventilatory assist on patient-ventilator interaction will also be explored.
- Being tested
- Neurally Adjusted Ventilatory Assist
- Keywords
- Mechanical ventilation, Non invasive Ventilation, Patient-ventilator interaction, Pressure support, Neurally adjusted ventilatory assist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally Adjusted Ventilatory AssistDevice
Also called NAVA
Non invasive ventilation under Neurally adjusted Ventilatory Assist
| Study group | Role | What they receive |
|---|---|---|
| Pressure support | No intervention | Non invasive ventilation under pressure support (PS) |
| Neurally Adjusted Ventilatory Assist | Active comparator | Non invasive ventilation under Neurally Adjusted ventilatory Assist Receives: Device: Neurally Adjusted Ventilatory Assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-ventilator synchronization parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Invasive VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital St Luc, Brussels, Centre Hospitalier Universitaire de Liege, University of Lausanne Hospitals, Notre Dame de Grace Hospital, Gosselies
- Investigators
- Didier Tassaux, MD, Study director, HUG, University hospital Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074866
- Sponsor's protocol ID
- NAVA_NIV
- Status last verified
- Jan 2010
- First submitted
- 23 Feb 2010
- Last updated
- 21 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neurally Adjusted Ventilatory Assist (NAVA) on Improving Patient-ventilator Interaction in Patients Undergoing Ventilation for Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT01074866
- Acronym / sponsor ID
- NAVA_NIV
- Keywords
- Mechanical ventilation, Non invasive Ventilation, Patient-ventilator interaction, Pressure support, Neurally adjusted ventilatory assist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University Hospital St Luc, Brussels, Centre Hospitalier Universitaire de Liege, University of Lausanne Hospitals, Notre Dame de Grace Hospital, Gosselies
- Study start
- Jul 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Feb 2010 (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 present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin.
Detailed description
The present study aims to compare various parameters reflecting patient-ventilator synchrony during standard pressure support (PS) and Neurally Adjusted Ventilatory assist (NAVA) in a group of patients receiving non invasive ventilation (NIV)for an episode of acute respiratory failure of various origin. The subgroup of COPD patients will be analyzed separately. The effects of various setting of Neurally adjusted ventilatory assist on patient-ventilator interaction will also be explored.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pressure support | No intervention | –Non invasive ventilation under pressure support (PS) |
| Neurally Adjusted Ventilatory Assist | Active comparator | Device: Neurally Adjusted Ventilatory AssistNon invasive ventilation under Neurally Adjusted ventilatory Assist |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the ICU and treated with Non invasive ventilation for acute respiratory failure of any origin
Key exclusion criteria (8 listed)
- severe hypoxemia requiring an FIO2>0.6
- hemodynamic instability
- known oesophageal problem
- active upper gastro-intestinal bleeding
- any other contraindication to the insertion of a naso-gastric tube
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 AssistAlso: NAVANon invasive ventilation under Neurally adjusted Ventilatory Assist | Device | Neurally Adjusted Ventilatory Assist |
Primary outcome
Patient-ventilator synchronization parameters
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 21 Sep 2012.
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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.
Didier Tassaux, MD study director
HUG, University hospital Geneva
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurally Adjusted Ventilatory Assist in people with Non Invasive Ventilation and Patient Ventilator Interaction, run by University Hospital, Geneva at 4 sites in 2 countries.
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 1 inclusion and 8 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 21 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Switzerland. 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?
Patient-ventilator synchronization parameters. 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 21 Sep 2012.