Status:
COMPLETED
Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Healthy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 diaph...
Eligibility Criteria
Inclusion
- Subject has given written informed consent.
- Male or female, aged 18 - 80 years (extremes included).
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00941044
Start Date
July 1 2009
End Date
January 1 2010
Last Update
February 5 2010
Active Locations (1)
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1
Department of Intensive Care Medicine, University Hospital - Inselspital
Bern, Canton of Bern, Switzerland, 3010