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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthieu SCHMIDT, Pierre and Marie Curie University
ClinicalTrials.gov Identifier:
NCT01280760
First received: January 19, 2011
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Weaning Period
Other: Device: Neurally Adjusted Ventilatory Assistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)

Further study details as provided by Pierre and Marie Curie University:

Primary Outcome Measures:
  • Triggering delay [ Time Frame: Every inspiration, for 10 minutes ] [ Designated as safety issue: No ]
    Duration between the onset of neural inspiration and the onset of insufflation


Secondary Outcome Measures:
  • Cycling off delay [ Time Frame: Every inspiration, for 10 minutes ] [ Designated as safety issue: No ]
    Delay between the end of neural inspiration and the end of insufflation


Enrollment: 16
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

NIV required on post extubation period

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01280760

Locations
France
Groupe Hospitalier Pitié Salpétrière, Department of intensive care and pneumology
Paris, France, 75013
Sponsors and Collaborators
Pierre and Marie Curie University
  More Information

No publications provided by Pierre and Marie Curie University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthieu SCHMIDT, Dr, Pierre and Marie Curie University
ClinicalTrials.gov Identifier: NCT01280760     History of Changes
Other Study ID Numbers: UPMC
Study First Received: January 19, 2011
Last Updated: December 18, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

ClinicalTrials.gov processed this record on October 16, 2014