AnesthesiaNCT01903343
Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers
An observational study of Anesthesia, run by University of Dundee at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- shear wave elastography
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Fit healthy male volunteers between 18 and 35 years of age.
- Participants with an ASA score of 1.
- Capacity to provide informed consent.
Who cannot join
- All females.
- Male participants aged <18 years and >35 years of age.
- ASA score 2 or above.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Anaesthesia, Ninewells Hospital & Medical School
Dundee, DD19SY
About this study
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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- shear wave elastography
- Keywords
- Shear wave, Elastography, Repeatability and Reproducibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shear wave elastographyDevice
ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Single group of healthy male medical students at Ninewells Hospital \& Medical School, Dundee. Receives: Device: shear wave elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours
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
Measured: 4 hours
Secondary outcomes (1)
Video Young's Modulus
To video changes in tissue stiffness (using the elastography colour map) in concert with changes in the B-Mode image
Measured: max 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startOct 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graeme A McLeod, MBChB FRCA, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903343
- Sponsor's protocol ID
- 2013AN01
- Status last verified
- May 2019
- First submitted
- 11 Jul 2013
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19130163Evans 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.
PubMed 21122101Liu 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.
PubMed 21320084Neal 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.
PubMed 20216027Neal 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.
PubMed 20216019
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Reproducibility of the Measurement of Young's Modulus Using Shear Wave Elastography in Volunteers
- ClinicalTrials.gov ID
- NCT01903343
- Acronym / sponsor ID
- 2013AN01
- Conditions
- Anesthesia
- Keywords
- Shear wave, Elastography, Repeatability and Reproducibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: shear wave elastographySingle group of healthy male medical students at Ninewells Hospital \& Medical School, Dundee. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Fit healthy male volunteers between 18 and 35 years of age.
- Participants with an ASA score of 1.
- Capacity to provide informed consent.
Key exclusion criteria (3 listed)
- All females.
- Male participants aged <18 years and >35 years of age.
- ASA score 2 or above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| shear wave elastographyultrasound | Device | Healthy Volunteers |
Primary outcome
To determine the reproducibility of Young's modulus in volunteers using shear wave elastography
Time frame: 4 hours
To determine the reproducibility of Young's modulus in volunteers using shear wave elastography
To determine the repeatability Young's modulus in volunteers using shear wave elastography
Time frame: 4 hours
To determine the repeatability Young's modulus in volunteers using shear wave elastography
1 secondary outcome
Video Young's Modulus
Time frame: max 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Background: PubMed 19130163Macfarlane 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.
- Background: PubMed 21122101Evans 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.
- Background: PubMed 21320084Liu 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.
- Background: PubMed 20216027Neal 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.
- Background: PubMed 20216019Neal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graeme A McLeod, MBChB FRCA principal investigator
NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the reproducibility of Young's modulus in volunteers using shear wave elastography (time frame: 4 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01903343, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.