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Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Helmet

Study of the Benefit of the NAVA Mode Versus PSV Mode on Patient Ventilator Asynchrony During Non Invasive Ventilation With Helmet

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01161875
Acronym
NAVAHELMET
Enrollment
10
Registered
2010-07-14
Start date
2009-11-30
Completion date
2010-12-31
Last updated
2011-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Invasive Positive-Pressure Ventilation

Brief 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. 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.

Interventions

DEVICENeurally Adjusted Ventilatory Assistance

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

Sponsors

Pierre and Marie Curie University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with increased risk of postoperative ventilatory dysfunction following abdominal aortic surgery

Exclusion criteria

* Contra-indication to non-invasive ventilation pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Triggering delayEvery inspiration, for 10 minutesDuration between the onset of neural inspiration and the onset of insufflation

Secondary

MeasureTime frameDescription
Cycling off delayEvery inspiration, for 10 minutesDelay between the end of neural inspiration and the end of insufflation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026