Weaning PeriodNAVA-NIVNCT01280760
Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)
An observational study of Weaning Period, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. 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 to 90 years
- Conditions the study is for
- Weaning Period
- What is being tested?
- Device: Neurally Adjusted Ventilatory Assistance
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to May 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NIV required on post extubation period
Who may be able to join
- Patients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning.
Who cannot join
- Contra-indication to non-invasive ventilation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Pitié Salpétrière, Department of intensive care and pneumology
Paris, 75013
About this study
Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. The presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is to record the diaphragmatic electrical activity and to control the ventilator. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in NIV
- Conditions
- Weaning Period
- Being tested
- Device: Neurally Adjusted Ventilatory Assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Neurally Adjusted Ventilatory AssistanceOther
Device: Neurally Adjusted Ventilatory Assistance
In ICU following extubation NIV was performed as follows:
facial mask with PSV/NIV mode to define settings for NAVA ventilation facial use with NAVA/NIV mode
| Study group | Role | What they receive |
|---|---|---|
| Non invasive ventilation | Non-invasive ventilation after invasive mechanical ventilation weaning Receives: Other: Device: Neurally Adjusted Ventilatory Assistance |
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 posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMay 2011
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 Weaning PeriodStudies 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
- 16 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280760
- Sponsor's protocol ID
- UPMC
- Acronym
- NAVA-NIV
- Status last verified
- Dec 2013
- First submitted
- 19 Jan 2011
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt M, Dres M, Raux M, Deslandes-Boutmy E, Kindler F, Mayaux J, Similowski T, Demoule A. Neurally adjusted ventilatory assist improves patient-ventilator interaction during postextubation prophylactic noninvasive ventilation. Crit Care Med. 2012 Jun;40(6):1738-44. doi: 10.1097/CCM.0b013e3182451f77.
PubMed 22610179
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)
- ClinicalTrials.gov ID
- NCT01280760
- Acronym / sponsor ID
- NAVA-NIV / UPMC
- Conditions
- Weaning Period
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Jan 2011 (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 (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. The presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is to record the diaphragmatic electrical activity and to control the ventilator. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in NIV
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non invasive ventilation | – | Other: Device: Neurally Adjusted Ventilatory AssistanceNon-invasive ventilation after invasive mechanical ventilation weaning |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NIV required on post extubation period
Key inclusion criteria (1 listed)
- Patients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning.
Key exclusion criteria (2 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 |
|---|---|---|
| Device: Neurally Adjusted Ventilatory AssistanceDevice: Neurally Adjusted Ventilatory Assistance In ICU following extubation NIV was performed as follows: facial mask with PSV/NIV mode to define settings for NAVA ventilation facial use with NAVA/NIV mode | Other | Non invasive ventilation |
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 19 Dec 2013.
- Derived from this study: PubMed 22610179Schmidt M, Dres M, Raux M, Deslandes-Boutmy E, Kindler F, Mayaux J, Similowski T, Demoule A. Neurally adjusted ventilatory assist improves patient-ventilator interaction during postextubation prophylactic noninvasive ventilation. Crit Care Med. 2012 Jun;40(6):1738-44. doi: 10.1097/CCM.0b013e3182451f77.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Weaning Period, 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 2 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 19 Dec 2013. 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?
On the ClinicalTrials.gov record for NCT01280760, 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 19 Dec 2013.