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Completed

NCT Number: NCT00941044

Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Intensive Care Medicine, University Hospital - Inselspital

Bern, Canton of Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Neurally Adjusted Ventilatory Assist

Device

application of non-invasive NAVA in healthy volunteers

Primary outcomes

  1. changes in mean inspiratory airway pressure

    Time frame: beginning to end of study

Secondary outcomes

  1. changes in respiratory pattern

    Time frame: begin to end of study

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 17, 2009
Registry last updated
Feb 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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