Clinical trial NCT00941044: Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers
Official title: Unloading of the Respiratory Muscles Using Non-invasive Neurally Adjusted Ventilatory Assist in Healthy, Resistively Loaded Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: non-invasive ventilation
diaphragm
electrical activity
neurally adjusted ventilatory assist
volunteers
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2009-07-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 diaphragm. The investigators will study the effects of non-invasive NAVA in respiratory muscle unloading in healthy volunteers.


Eligibility 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).

Primary outcomes:
measure: changes in mean inspiratory airway pressure
timeFrame: beginning to end of study
Secondary outcomes:
measure: changes in respiratory pattern
timeFrame: begin to end of study
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Intensive Care Medicine, University Hospital - Inselspital
Study officials:
References:
citation: Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.
citation: Tuchscherer D, Z'graggen WJ, Passath C, Takala J, Sinderby C, Brander L. Neurally adjusted ventilatory assist in patients with critical illness-associated polyneuromyopathy. Intensive Care Med. 2011 Dec;37(12):1951-61. doi: 10.1007/s00134-011-2376-0. Epub 2011 Nov 3.