Non-Invasive Positive-Pressure VentilationNAVAHELMETNCT01161875
Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Helmet
An observational study of Non-Invasive Positive-Pressure Ventilation, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non invasive ventilation and induces air leaks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Invasive Positive-Pressure Ventilation
- What is being tested?
- Neurally Adjusted Ventilatory Assistance
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Dec 2010
- Phase
- Observational
- 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
Study population: Postoperative period
Who may be able to join
- Patients with increased risk of postoperative ventilatory dysfunction following abdominal aortic surgery
Who cannot join
- Contra-indication to non-invasive ventilation pregnancy.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Pitie Salpetriere, Department of Anesthesiology and Critical Care
Paris, 75013
About this study
Official title: Study of the Benefit of the NAVA Mode Versus PSV Mode on Patient Ventilator Asynchrony During Non Invasive Ventilation With Helmet
Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non invasive ventilation and induces air leaks. The use of a helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface. However, the high dead space related to helmet volume is responsible for asynchrony between patient demand and ventilatory support delivery. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies.
- Being tested
- Neurally Adjusted Ventilatory Assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally Adjusted Ventilatory AssistanceDevice
In ICU following abdominal aortic surgery, in extubated patient, non-invasive ventilation was performed as follows:
- facial mask with non-invasive pressure support ventilation mode to define settings for helmet ventilation
- helmet use with non-invasive pressure support ventilation mode to define adequate settings
- helmet use with neurally adjusted ventilatory assist mode, based on previous settings
What is being measured
The primary outcome is the main question the study is designed to answer.
Triggering delay
Duration between the onset of neural inspiration and the onset of insufflation
Measured: Every inspiration, for 10 minutes
Secondary outcomes (1)
Cycling off delay
Delay between the end of neural inspiration and the end of insufflation
Measured: Every inspiration, for 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Invasive Positive-Pressure VentilationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre and Marie Curie University
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Similowski, MD, PhD, Study director, Groupe Hospitalier Pitie-SalpetriereMathieu RAUX, MD, PhD, Principal investigator, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161875
- Sponsor's protocol ID
- Nava Helmet #1
- Acronym
- NAVAHELMET
- Status last verified
- Nov 2009
- First submitted
- 13 Jul 2010
- Last updated
- 5 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Benefit of the NAVA Mode Versus PSV Mode on Patient Ventilator Asynchrony During Non Invasive Ventilation With Helmet
- ClinicalTrials.gov ID
- NCT01161875
- Acronym / sponsor ID
- NAVAHELMET / Nava Helmet #1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Jul 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.
Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non invasive ventilation and induces air leaks. The use of a helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface. However, the high dead space related to helmet volume is responsible for asynchrony between patient demand and ventilatory support delivery. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative period
Key inclusion criteria (1 listed)
- Patients with increased risk of postoperative ventilatory dysfunction following abdominal aortic surgery
Key exclusion criteria (1 listed)
- Contra-indication to non-invasive ventilation pregnancy.
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 AssistanceIn ICU following abdominal aortic surgery, in extubated patient, non-invasive ventilation was performed as follows: * facial mask with non-invasive pressure support ventilation mode to define settings for helmet ventilation * helmet use with non-invasive pressure support ventilation mode to define adequate settings * helmet use with neurally adjusted ventilatory assist mode, based on previous settings | Device | – |
Primary outcome
Triggering delay
Time frame: Every inspiration, for 10 minutes
Duration between the onset of neural inspiration and the onset of insufflation
1 secondary outcome
Cycling off delay
Time frame: Every inspiration, for 10 minutes
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 5 Aug 2011.
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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.
Thomas Similowski, MD, PhD study director
Groupe Hospitalier Pitie-Salpetriere
Mathieu RAUX, MD, PhD principal investigator
Groupe Hospitalier Pitie-Salpetriere
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Invasive Positive-Pressure Ventilation, 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 1 inclusion and 1 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 5 Aug 2011. 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?
Triggering delay (time frame: Every inspiration, for 10 minutes). 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 5 Aug 2011.