Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Helmet (NAVAHELMET)

This study has been completed.
Sponsor:
Information provided by:
Pierre and Marie Curie University
ClinicalTrials.gov Identifier:
NCT01161875
First received: July 13, 2010
Last updated: August 4, 2011
Last verified: November 2009
  Purpose

Non invasive ventilation has been proposed to reduce the incidence of ventilatory dysfunction following abdominal aortic surgery. However, the nasogastric tube reduces the airtightness of the facial mask used to perform non invasive ventilation and induces air leaks. The use of a helmet reduces air leaks, thus seems adequate to ensure patient-ventilator interface. However, the high dead space related to helmet volume is responsible for asynchrony between patient demand and ventilatory support delivery. The investigators hypothesized driving the ventilator based on a neural signal (diaphragm electrical activity) would reduce patient-ventilator asynchronies.


Condition Intervention
Non-Invasive Positive-Pressure Ventilation
Device: Neurally Adjusted Ventilatory Assistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Benefit of the NAVA Mode Versus PSV Mode on Patient Ventilator Asynchrony During Non Invasive Ventilation With Helmet

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


Estimated Enrollment: 10
Study Start Date: November 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Neurally Adjusted Ventilatory Assistance

    In ICU following abdominal aortic surgery, in extubated patient, non-invasive ventilation was performed as follows:

    • facial mask with non-invasive pressure support ventilation mode to define settings for helmet ventilation
    • helmet use with non-invasive pressure support ventilation mode to define adequate settings
    • helmet use with neurally adjusted ventilatory assist mode, based on previous settings
  Eligibility

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

Postoperative period

Criteria

Inclusion Criteria:

  • Patients with increased risk of postoperative ventilatory dysfunction following abdominal aortic surgery

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: NCT01161875

Locations
France
Groupe Hospitalier Pitie Salpetriere, Department of Anesthesiology and Critical Care
Paris, France, 75013
Sponsors and Collaborators
Pierre and Marie Curie University
Investigators
Study Director: Thomas Similowski, MD, PhD Groupe Hospitalier Pitie-Salpetriere
Principal Investigator: Mathieu RAUX, MD, PhD Groupe Hospitalier Pitie-Salpetriere
  More Information

No publications provided

Responsible Party: Professor Thomas SIMILOWSKI, Groupe Hospitalier Pitie Salpetriere
ClinicalTrials.gov Identifier: NCT01161875     History of Changes
Other Study ID Numbers: Nava Helmet #1
Study First Received: July 13, 2010
Last Updated: August 4, 2011
Health Authority: France: Institutional Ethical Committee

ClinicalTrials.gov processed this record on July 29, 2014