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Completed

NCT Number: NCT01426178

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

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.

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Key information

Conditions

Respiratory Insufficiency Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)

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.

Primary outcomes

  1. Asynchrony rate defined as a percentage of the total respiratory rate

    Time frame: at 90 minutes

Secondary outcomes

  1. - Number of patients presenting a high asynchrony rate (>10%)

    Time frame: at 90 minutes

  2. Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set

    Time frame: at 90 minutes

  3. Patient comfort

    Time frame: at 90 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 31, 2011
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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