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

NCT ID: NCT01903343

Last Updated: 2019-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteers

Single group of healthy male medical students at Ninewells Hospital \& Medical School, Dundee.

shear wave elastography

Intervention Type DEVICE

ultrasound

Interventions

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shear wave elastography

ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Dundee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Graeme A McLeod, MBChB FRCA

Role: PRINCIPAL_INVESTIGATOR

NHS Tayside

Locations

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Department of Anaesthesia, Ninewells Hospital & Medical School

Dundee, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 19130163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21122101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21320084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20216027 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20216019 (View on PubMed)

Other Identifiers

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2013AN01

Identifier Type: -

Identifier Source: org_study_id

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