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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161875
First Posted: July 14, 2010
Last Update Posted: August 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pierre and Marie Curie University
  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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Professor Thomas SIMILOWSKI, Groupe Hospitalier Pitie Salpetriere
ClinicalTrials.gov Identifier: NCT01161875     History of Changes
Other Study ID Numbers: Nava Helmet #1
First Submitted: July 13, 2010
First Posted: July 14, 2010
Last Update Posted: August 5, 2011
Last Verified: November 2009