Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring

NCT ID: NCT02589899

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-12-31

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).

Conditions

Electric Impedance; Human; Hypodermic Needles; Tissues; Nerve

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Needle placement in different tissue types

Needle placement and impedance measurements in different tissue types

Needle placement in different tissue types

Intervention Type: OTHER

Bioimpedance will be measured for needle positions in different tissue types

Interventions

Needle placement in different tissue types

Bioimpedance will be measured for needle positions in different tissue types

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• American society of anaesthesiologists score (ASA) 1 or 2
• Volunteers that have given informed written consent

Exclusion Criteria

• Volunteers that cannot cooperate for the examination
• Volunteers with neurologic disease, nerve- or vascular impairment
• ASA > 2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Axel Rudolf Sauter

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital

Oslo, Oslo County, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Axel R Sauter, PhD

Role: CONTACT

sauter@start.no

23073700 ext. +47

Facility Contacts

Leiv Arne Rosseland, PhD, Professor

Role: primary

l.a.rosseland@medisin.uio.no

23070000 ext. +41

References

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.

Reference Type: BACKGROUND

PMID: 25902898 (View on PubMed)

Other Identifiers

impedance monitoring 1/2015

Identifier Type: -

Identifier Source: org_study_id