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Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00941044
First received: July 16, 2009
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in respiratory pattern [ Time Frame: begin to end of study ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00941044

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

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

Keywords provided by University Hospital Inselspital, Berne:
non-invasive ventilation
diaphragm
electrical activity
neurally adjusted ventilatory assist
volunteers

ClinicalTrials.gov processed this record on November 25, 2014