Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

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.

Layout table for study information
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
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine



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.



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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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
Layout table for location information
France
CHU Clermont-Ferrand
Clermont-Ferrand, France
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01426178    
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:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases