Clinical trial NCT01903343: Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers
Official title: Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Shear wave
Elastography
Repeatability and Reproducibility
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study of 8 subjects - volunteer medical students. Recruitment: Male medical students at Ninewells Hospital \& Medical School, Dundee.

Male medical students will be e-mailed by the chief investigator.

Brief summary: The aim of the study is to assess the accuracy of shear wave elastography in volunteers. Shear wave elastography is a non-invasive, non-painful measure of tissue stiffness obtained using an ultrasound machine. It may be easier to think of shear wave elastography as a special type of ultrasound imaging which gives doctors a colour picture of body structures based on their stiffness.

Detailed description: Shear wave elastography is a quantitative ultrasound modality increasingly used to differentiate between "hard" breast cancer masses and "soft" normal tissue. Unlike strain elastography, shear wave elastography applies a non-compressive longitudinal acoustic radiation force to underlying tissues, inducing transverse shear waves. Studies in Thiel embalmed human cadavers have shown significant differences in Young's modulus between intraneural and extraneural tissue, and ready colour differentiation between tissues.

Therefore, before clinical application, we wish to measure the repeatability and reproducibility of Young's modulus of intraneural and extraneural tissue in volunteers. For measurement, a region of interest (ROI) will be selected over the appropriate nerve and adjacent tissue. The ROI results will be regarded as paired data. Paired data will be measured over and adjacent to the interscalene C5 nerve root, infraclavicular lateral cord, musculocutaneous, median, femoral, saphenous and sciatic nerves.

Eligibility criteria: Inclusion Criteria:

* Fit healthy male volunteers between 18 and 35 years of age.
* Participants with an ASA score of 1.
* Capacity to provide informed consent.

Exclusion Criteria:

* All females.
* Male participants aged \<18 years and \>35 years of age.
* ASA score 2 or above.

Primary outcomes:
measure: To determine the reproducibility of Young's modulus in volunteers using shear wave elastography
timeFrame: 4 hours
measure: To determine the repeatability Young's modulus in volunteers using shear wave elastography
timeFrame: 4 hours
Secondary outcomes:
measure: Video Young's Modulus
timeFrame: max 2 minutes
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Department of Anaesthesia, Ninewells Hospital & Medical School
Study officials:
affiliation: NHS Tayside
name: Graeme A McLeod, MBChB FRCA
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Evans A, Whelehan P, Thomson K, McLean D, Brauer K, Purdie C, Jordan L, Baker L, Thompson A. Quantitative shear wave ultrasound elastography: initial experience in solid breast masses. Breast Cancer Res. 2010;12(6):R104. doi: 10.1186/bcr2787. Epub 2010 Dec 1.
citation: Liu SS, YaDeau JT, Shaw PM, Wilfred S, Shetty T, Gordon M. Incidence of unintentional intraneural injection and postoperative neurological complications with ultrasound-guided interscalene and supraclavicular nerve blocks. Anaesthesia. 2011 Mar;66(3):168-74. doi: 10.1111/j.1365-2044.2011.06619.x.
citation: Neal JM. Ultrasound-guided regional anesthesia and patient safety: An evidence-based analysis. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S59-67. doi: 10.1097/AAP.0b013e3181ccbc96.
citation: Neal JM, Brull R, Chan VW, Grant SA, Horn JL, Liu SS, McCartney CJ, Narouze SN, Perlas A, Salinas FV, Sites BD, Tsui BC. The ASRA evidence-based medicine assessment of ultrasound-guided regional anesthesia and pain medicine: Executive summary. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S1-9. doi: 10.1097/AAP.0b013e3181d22fe0.