This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

This study has been completed.
Information provided by:
University Hospital Inselspital, Berne Identifier:
First received: July 16, 2009
Last updated: February 4, 2010
Last verified: February 2010
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assistance to spontaneous breathing based on the detection of the electrical activity of the diaphragm. The investigators will study the effects of non-invasive NAVA in respiratory muscle unloading in healthy volunteers.

Condition Intervention Phase
Healthy Device: Neurally adjusted ventilatory assist Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Unloading of the Respiratory Muscles Using Non-invasive Neurally Adjusted Ventilatory Assist in Healthy, Resistively Loaded Volunteers

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • changes in mean inspiratory airway pressure [ Time Frame: beginning to end of study ]

Secondary Outcome Measures:
  • changes in respiratory pattern [ Time Frame: begin to end of study ]

Estimated Enrollment: 16
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: non-invasive NAVA
application of non-invasive neurally adjusted ventilatory assist in healthy volunteers
Device: Neurally adjusted ventilatory assist
application of non-invasive NAVA in healthy volunteers


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject has given written informed consent.
  • Male or female, aged 18 - 80 years (extremes included).

Exclusion Criteria:

  • Pregnant or breast-feeding female. A pregnancy test will be performed in all female volunteers less than 60 yrs of age.
  • Known intolerance or allergy against local anesthetic drugs such as procain, lidoocaine, xylocain.
  • Any contraindication to the insertion of a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture, bleeding disorder with evidence of active bleeding.
  • Presence or suspicion of diaphragm injury.
  • Prior medical history that might contribute to a disturbance of the neural system, including, but not limited to: diabetes, prior critical illness, carcinoma, uremia, vitamin B12 deficiency, chronic liver disease, alcohol abuse, malabsorption (sprue), HIV, Lyme disease, Lymphoma, multiple myeloma, hypothyroidism, systemic vasculitis, abnormalities on physical examination of peripheral nervous system (pallesthesia, impaired muscle strength according to the MRC Scale for Muscle Examination in 12 Muscle groups).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00941044

Department of Intensive Care Medicine, University Hospital - Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lukas Brander, MD, University Hospital - Inselspital Identifier: NCT00941044     History of Changes
Other Study ID Numbers: KEK BE 062/09
Study First Received: July 16, 2009
Last Updated: February 4, 2010

Keywords provided by University Hospital Inselspital, Berne:
non-invasive ventilation
electrical activity
neurally adjusted ventilatory assist
volunteers processed this record on August 23, 2017