Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

NCT00941044 | Completed Phase 1

• 1 other identifier: KEK BE 062/09
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• changes in mean inspiratory airway pressure

  beginning to end of study

Secondary Outcomes (1)

• changes in respiratory pattern

  begin to end of study

Study Arms (1)

non-invasive NAVA

EXPERIMENTAL

application of non-invasive neurally adjusted ventilatory assist in healthy volunteers

Device: Neurally adjusted ventilatory assist

Interventions

Neurally adjusted ventilatory assist DEVICE

application of non-invasive NAVA in healthy volunteers

non-invasive NAVA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has given written informed consent.
• Male or female, aged 18 - 80 years (extremes included).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Intensive Care Medicine, University Hospital - Inselspital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 10581089 BACKGROUND

• 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.

  PMID: 22048718 DERIVED

MeSH Terms

Interventions

Interactive Ventilatory Support

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 17, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 5, 2010

Record last verified: 2010-02

Locations

CH (1)