Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941044
• Other study ID #: KEK BE 062/09
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2009
• Last updated: February 4, 2010
• Start date: July 2009
• Est. completion date: January 2010

Study information

• Verified date: February 2010
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Neurally adjusted ventilatory assist
application of non-invasive NAVA in healthy volunteers

Locations

Country	Name	City	State
Switzerland	Department of Intensive Care Medicine, University Hospital - Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindström L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in mean inspiratory airway pressure		beginning to end of study	No
Secondary	changes in respiratory pattern		begin to end of study	No