Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring
1 other identifier
observational
32
1 country
1
Brief Summary
A novel algorithm for bioimpedance measurements to detect nerve tissue, and discriminate it from other tissue types has been developed in a porcine model, by analysing a complex impedance dataset based on multiple measurement frequencies. It must now be confirm that the previous results are applicable in humans. Measurements from 24 predefined needle positions will be obtained in 16 of the 32 volunteers that are included in the study (part A). A new algorithm to detect nerve tissue will be developed based on these measurement results. Further impedance algorithms will be developed for other tissue type. The efficacy of the algorithms (sensitivity and specificity) will be evaluated in the 16 following volunteers (part B).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 8, 2016
June 1, 2016
2.2 years
October 22, 2015
June 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Success in the identification of nerve tissue by the use of an algorithm based on a multiple frequency impedance measurement (MFIM) algorithm. The outcome is binary (success vs failure).
From day 1 up to 12 months
Study Arms (1)
Needle placement in different tissue types
Needle placement and impedance measurements in different tissue types
Interventions
Bioimpedance will be measured for needle positions in different tissue types
Eligibility Criteria
Healthy volunteers
You may qualify if:
- Age ≥ 18 years
- American society of anaesthesiologists score (ASA) 1 or 2
- Volunteers that have given informed written consent
You may not qualify if:
- Volunteers that cannot cooperate for the examination
- Volunteers with neurologic disease, nerve- or vascular impairment
- ASA \> 2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, Oslo County, 0424, Norway
Related Publications (1)
Kalvoy H, Sauter AR. Detection of intraneural needle-placement with multiple frequency bioimpedance monitoring: a novel method. J Clin Monit Comput. 2016 Apr;30(2):185-92. doi: 10.1007/s10877-015-9698-3. Epub 2015 Apr 23.
PMID: 25902898BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 28, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
June 8, 2016
Record last verified: 2016-06