Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring

Human Clinical Trial

Official title:

Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02589899
• Other study ID #: impedance monitoring 1/2015
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2015
• Last updated: June 7, 2016
• Start date: October 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Oslo University Hospital
• Contact: Axel R Sauter, PhD
• Phone: 23073700
• Email: sauter[@]start.no
• Is FDA regulated: No
• Health authority: Norway: Ethics CommitteeNorway: Data Protection Authority
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Electric Impedance
• Human
• Hypodermic Needles
• Nerve
• Tissues

Intervention

Other:
• Needle placement in different tissue types
Bioimpedance will be measured for needle positions in different tissue types

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Kalvøy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No