Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Device: Neurally adjusted ventilatory assist

• Registration Number: NCT00941044
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-04
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
non-invasive NAVA	Neurally adjusted ventilatory assist	application of non-invasive neurally adjusted ventilatory assist in healthy volunteers

Primary Outcome Measures

Name	Time	Method
changes in mean inspiratory airway pressure	beginning to end of study

Secondary Outcome Measures

Name	Time	Method
changes in respiratory pattern	begin to end of study

Trial Locations

Locations (1)

Department of Intensive Care Medicine, University Hospital - Inselspital; 🇨🇭 Bern, Switzerland