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Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01426178
Enrollment
17
Registered
2011-08-31
Start date
2011-07-01
Completion date
2012-01-01
Last updated
2026-08-05

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

Conditions

Respiratory Insufficiency

Keywords

Respiratory Insufficiency, Respiration, Artificial, Intermittent Positive-Pressure Ventilation, Neurally Adjusted Ventilatory Assist, Non Invasive Ventilation

Brief summary

Main hypothesis is that Neurally Adjusted Ventilatory Assist (NAVA) allows asynchrony reduction in non invasive ventilation (NIV) in comparison with reference Pressure Support (PSV) mode. The purpose of the protocol is to compare asynchrony rate between periods of pressure support and periods of NAVA.

Detailed description

After written information and consent, patients are randomised in two groups: NAVA first or PSV first. They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter. A standardised set of 1 hour of non-invasive ventilation is started. Depending on the randomisation group, patients start with a 30 minutes set of NIV with NAVA settings or with a 30 minutes set of NIV with PSV settings. A 30-minute watch-out period is then delivered with no mechanical ventilation. Then a second 30-minute set of NIV in the other settings (NAVA or PSV depending on the randomisation) is delivered. During each set of NIV, flow, volume, pressure and EADi are recorded during 10 minutes, after a 10-minute period of equilibration. Recordings will be processed by two blind investigators in order to count the number of asynchronies. In case of disagreement between investigators, a third one will be interviewed.

Interventions

DEVICENeurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)

After written information and consent, patients are randomised in two groups: NAVA first or PSV first. They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter.

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

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

Inclusion criteria

* \- Patient older then 18 years * Patient requiring first non invasive ventilation set because of acute respiratory failure

Exclusion criteria

* Patients protected by the law * Pregnant women

Design outcomes

Primary

MeasureTime frame
Asynchrony rate defined as a percentage of the total respiratory rateat 90 minutes

Secondary

MeasureTime frame
- Number of patients presenting a high asynchrony rate (>10%)at 90 minutes
Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA setat 90 minutes
Patient comfortat 90 minutes

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean-Michel CONSTANTIN

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026