Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00941044

Enrollment

Registered

2009-07-17

Start date

2009-07-31

Completion date

2010-01-31

Last updated

2010-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

non-invasive ventilation, diaphragm, electrical activity, neurally adjusted ventilatory assist, volunteers

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.

Interventions

DEVICENeurally adjusted ventilatory assist

application of non-invasive NAVA in healthy volunteers

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
changes in mean inspiratory airway pressure	beginning to end of study

Secondary

Measure	Time frame
changes in respiratory pattern	begin to end of study

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026