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

This study is currently recruiting participants.
Verified August 2011 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01426178
First received: July 7, 2011
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426178

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France
Contact: Patrick LACARIN     04 73 75 11 95     placarin@chu-clermontferrand.fr    
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
  More Information

No publications provided by University Hospital, Clermont-Ferrand

Additional 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
Study First Received: July 7, 2011
Last Updated: August 30, 2011
Health Authority: France: Ministry of Health

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
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013