Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Unloading of the Respiratory Muscles Using Non-invasive Neurally Adjusted Ventilatory Assist in Healthy, Resistively Loaded Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Device: Neurally adjusted ventilatory assist


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-invasive NAVA<br>application of non-invasive neurally adjusted ventilatory assist in healthy volunteers | Device: Neurally adjusted ventilatory assist<br>* application of non-invasive NAVA in healthy volunteers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in mean inspiratory airway pressure |  | beginning to end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in respiratory pattern |  | begin to end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive ventilation, diaphragm, electrical activity, neurally adjusted ventilatory assist, volunteers