Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
Primary Purpose
Respiratory Insufficiency
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Respiratory Insufficiency, Respiration, Artificial, Intermittent Positive-Pressure Ventilation, Neurally Adjusted Ventilatory Assist, Non Invasive Ventilation
Eligibility 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
Sites / Locations
- CHU Clermont-Ferrand
Outcomes
Primary Outcome Measures
Asynchrony rate defined as a percentage of the total respiratory rate
Secondary Outcome Measures
- Number of patients presenting a high asynchrony rate (>10%)
Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set
Patient comfort
Full Information
NCT ID
NCT01426178
First Posted
July 7, 2011
Last Updated
July 4, 2014
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT01426178
Brief Title
Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
Official Title
Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
Keywords
Respiratory Insufficiency, Respiration, Artificial, Intermittent Positive-Pressure Ventilation, Neurally Adjusted Ventilatory Assist, Non Invasive Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)
Intervention 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.
Primary Outcome Measure Information:
Title
Asynchrony rate defined as a percentage of the total respiratory rate
Time Frame
at 90 minutes
Secondary Outcome Measure Information:
Title
- Number of patients presenting a high asynchrony rate (>10%)
Time Frame
at 90 minutes
Title
Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set
Time Frame
at 90 minutes
Title
Patient comfort
Time Frame
at 90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel CONSTANTIN
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22661448
Citation
Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.
Results Reference
derived
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Neurally Adjusted Ventilatory Assist (NAVA) in NonInvasive Ventilation (NIV)
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