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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01426178
First Posted: August 31, 2011
Last Update Posted: July 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose

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.


Condition Intervention Phase
Respiratory Insufficiency Device: Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Asynchrony rate defined as a percentage of the total respiratory rate [ Time Frame: at 90 minutes ]

Secondary Outcome Measures:
  • - Number of patients presenting a high asynchrony rate (>10%) [ Time Frame: at 90 minutes ]
  • Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set [ Time Frame: at 90 minutes ]
  • Patient comfort [ Time Frame: at 90 minutes ]

Enrollment: 17
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Neurally 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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426178


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01426178     History of Changes
Other Study ID Numbers: CHU-0099
First Submitted: July 7, 2011
First Posted: August 31, 2011
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by University Hospital, Clermont-Ferrand:
Respiratory Insufficiency
Respiration, Artificial
Intermittent Positive-Pressure Ventilation
Neurally Adjusted Ventilatory Assist
Non Invasive Ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases