Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)
NAVA-NIV
1 other identifier
observational
16
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 19, 2011
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedDecember 19, 2013
December 1, 2013
2 months
January 19, 2011
December 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Triggering delay
Duration between the onset of neural inspiration and the onset of insufflation
Every inspiration, for 10 minutes
Secondary Outcomes (1)
Cycling off delay
Every inspiration, for 10 minutes
Study Arms (1)
Non invasive ventilation
Non-invasive ventilation after invasive mechanical ventilation weaning
Interventions
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
Eligibility Criteria
NIV required on post extubation period
You may qualify if:
- Patients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning.
You may not qualify if:
- Contra-indication to non-invasive ventilation
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Pitié Salpétrière, Department of intensive care and pneumology
Paris, 75013, France
Related Publications (1)
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.
PMID: 22610179DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
January 19, 2011
First Posted
January 21, 2011
Study Start
January 1, 2011
Primary Completion
March 1, 2011
Study Completion
May 1, 2011
Last Updated
December 19, 2013
Record last verified: 2013-12