Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV) (NAVA-NIV)

Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non-invasive ventilation and induces air leaks. The presence of leaks at the patient-mask interface can increase the risk of patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is to record the diaphragmatic electrical activity and to control the ventilator. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies in NIV

Study Overview

• Status: Completed
• Conditions: Weaning Period
• Intervention / Treatment: Other: Device: Neurally Adjusted Ventilatory Assistance

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Groupe Hospitalier Pitié Salpétrière, Department of intensive care and pneumology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

NIV required on post extubation period

Description

Inclusion Criteria:

Patients with increased risk of post-extubation ventilatory dysfunction following invasive mechanical ventilation weaning.

Exclusion Criteria:

• Contra-indication to non-invasive ventilation
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non invasive ventilation; Non-invasive ventilation after invasive mechanical ventilation weaning	Other: Device: Neurally Adjusted Ventilatory Assistance; Device: Neurally Adjusted Ventilatory Assistance In ICU following extubation NIV was performed as follows: facial mask with PSV/NIV mode to define settings for NAVA ventilation facial use with NAVA/NIV mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triggering delay	Duration between the onset of neural inspiration and the onset of insufflation	Every inspiration, for 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycling off delay	Delay between the end of neural inspiration and the end of insufflation	Every inspiration, for 10 minutes

Collaborators and Investigators

• Sponsor: Pierre and Marie Curie University

Publications and helpful links

General Publications

• Schmidt M, Dres M, Raux M, Deslandes-Boutmy E, Kindler F, Mayaux J, Similowski T, Demoule A. Neurally adjusted ventilatory assist improves patient-ventilator interaction during postextubation prophylactic noninvasive ventilation. Crit Care Med. 2012 Jun;40(6):1738-44. doi: 10.1097/CCM.0b013e3182451f77.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (Estimate): January 21, 2011

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: UPMC