Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring

• Conditions: Hypodermic Needles; Electric Impedance; Tissues; Nerve; Human

• Registration Number: NCT02589899
• Lead Sponsor: Oslo University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-07
• Last Update Posted: 2016-06-08
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway