Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers

Anesthesia Clinical Trial

Official title:

Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903343
• Other study ID #: 2013AN01
• Status: Completed
• Start date: October 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• shear wave elastography
ultrasound

Locations

Country	Name	City	State
United Kingdom	Department of Anaesthesia, Ninewells Hospital & Medical School	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View 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. — View Citation

Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7. Review. — View 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. Review. Erratum in: Reg Anesth Pain Med. 2010 May-Jun;35(2):325. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the reproducibility of Young's modulus in volunteers using shear wave elastography	To determine the reproducibility of Young's modulus in volunteers using shear wave elastography	4 hours
Primary	To determine the repeatability Young's modulus in volunteers using shear wave elastography	To determine the repeatability Young's modulus in volunteers using shear wave elastography	4 hours
Secondary	Video Young's Modulus	To video changes in tissue stiffness (using the elastography colour map) in concert with changes in the B-Mode image	max 2 minutes