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

U

University Hospital, Clermont-Ferrand

Status and phase

Completed
Phase 1

Conditions

Respiratory Insufficiency

Treatments

Device: Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)

Study type

Interventional

Funder types

Other

Identifiers

NCT01426178
CHU-0099

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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