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

Respiratory Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426178
• Other study ID #: CHU-0099
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2011
• Last updated: July 4, 2014
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchrony rate defined as a percentage of the total respiratory rate		at 90 minutes	Yes
Secondary	- Number of patients presenting a high asynchrony rate (>10%)		at 90 minutes	Yes
Secondary	Oxygenation evaluated as the PaO2 / FiO2 ratio at the end of considered NAVA set		at 90 minutes	Yes
Secondary	Patient comfort		at 90 minutes	Yes