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

Insel Gruppe AG, University Hospital Bern1 site in 1 country16 target enrollmentJuly 2009

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Insel Gruppe AG, University Hospital Bern
Enrollment: 16
Locations: 1
Primary Endpoint: changes in mean inspiratory airway pressure
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

January 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Insel Gruppe AG, University Hospital Bern

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).