Non-invasive Neurally Adjusted Ventilatory Assist in Healthy Volunteers

NCT ID: NCT00941044

Last Updated: 2010-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-01-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-invasive NAVA

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

Group Type EXPERIMENTAL

Neurally adjusted ventilatory assist

Intervention Type DEVICE

application of non-invasive NAVA in healthy volunteers

Interventions

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Neurally adjusted ventilatory assist

application of non-invasive NAVA in healthy volunteers

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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University Hospital - Inselspital

Locations

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Department of Intensive Care Medicine, University Hospital - Inselspital

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 10581089 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22048718 (View on PubMed)

Other Identifiers

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KEK BE 062/09

Identifier Type: -

Identifier Source: org_study_id

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