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

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ClinicalTrials.gov Identifier: NCT01426178
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
Study Start Date : July 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

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 Posted: August 31, 2011    Key Record Dates
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