Elasticity Imaging TechniquesELASTNCT04959058
EVALUATION OF BRACHIAL PLEXUS IN DIFFERENT ARM POSITION
A study testing Volunteer in people with Elasticity Imaging Techniques and Brachial Plexus Injury, run by Ataturk University.
Trial summary
In daily life,people protect their tissues against ischemia by constantly changing positions. In situations that cause unconsciousness such as anesthesia,people cannot react to the stress or pressure due to immobility.This prolongation of immobility can lead to reversible or irreversible damage to the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Elasticity Imaging Techniques, Brachial Plexus Injury
- What is being tested?
- Volunteer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2021to 1 Aug 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-II
- Volunteers
Who cannot join
- Upper extremity trauma
- Cervical trauma
- Muscle weakness
- Cervical disc herniation
- History of spine surgery
- Cranial surgery,
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- Neuromuscular disease
- Clinical diagnosis of brachial plexopathies
- Hyperlipidemia
- Diabetes mellitus
- Radiotherapy history in the cervical region
- Severely obese volunteers (body mass index> 35 kg / m2)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: EVALUATION OF BRACHIAL PLEXUS IN DIFFERENT ARM POSITIONS BY ELASTOGRAPHY
In daily life,people protect their tissues against ischemia by constantly changing positions. In situations that cause unconsciousness such as anesthesia,people cannot react to the stress or pressure due to immobility.This prolongation of immobility can lead to reversible or irreversible damage to the tissues.Therefore,not careful positioning in patients undergoing surgery can lead to serious complications.Peripheral nerve disorders are common in clinical practice.Electrodiagnostic studies continue to be the gold standard for the evaluation of nerve disorders.Elastography is a technique that measures the elastic properties of tissues as a new ultrasonography technology.Given the histological changes in diseased peripheral nerves, nerve elastography has begun to be studied as a noninvasive way to evaluate changes in nerve tissue composition.Elastography of the peripheral nerves has rarely been studied.
Primary aim in this study is to compare the elastography values of the brachial plexus in different arm and head positions and to contribute to elucidating the mechanism of nerve damage due to position.American Society of Anesthesiologists (ASA) I-II volunteers between the ages of 18-65 will be recruited to the study.The bilateral brachial plexus of each volunteer will be examined.Participants with upper extremity or cervical trauma, muscle weakness,cervical disc herniation or a history of spine or cranial surgery, neuromuscular disease, clinical diagnosis of brachial plexopathies, hyperlipidemia,diabetes mellitus or radiotherapy history in the cervical region,body mass index> 35 will not be taken.Before the procedure, the muscle strength of the upper extremity and cervical muscles will be examined and volunteers with muscle weakness will be excluded from the study.Measurements will be made together by two researchers who have at least 5 years of experience in ultrasonography.Measurements will be made in 3 different positions.When the arm and head are in neutral position, the head is turned to the opposite side and the head is turned to the opposite side, the brachial plexus in the supraclavicular region will be visualized by ultrasonography while the arm is in hyperabduction.The area between the upper boundary and the lower boundary of the plexus will be marked, and the values will be taken 5 times consecutively with the share wave elastography method and the elastic modulus,shear wave velocity will be recorded.
- Being tested
- Volunteer
- Keywords
- Brachial plexus, Elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolunteerDevice
An ultrasound machine will be used to calculate the elastographic value of the brachial plexus in three different positions.
| Study group | Role | What they receive |
|---|---|---|
| Volunteer | Other | This study has only one arm for the brachial plexus evaluation with ultrasound Receives: Device: Volunteer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary aim in this study is to compare the baseline measurements of elastography values (kPa-kilopascal) of the brachial plexus in different arm and head positions.
Measured: Prestudy will be conducted with volunteers and the measurement will take about 15 minutes per case for three different case position as described in thestudy will be conducted with volunteers and the measurement will take about 15 minutes per subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start15 Jul 2021 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elasticity Imaging TechniquesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Measurements will be made in 3 different positions for a participant
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Ince, Ataturk University
- Investigators
- Ilker Ince, Principal investigator, Ataturk University, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959058
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/103
- Acronym
- ELAST
- Status last verified
- Jul 2021
- First submitted
- 29 May 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakaya MA, Darcin K, Ince I, Yenigun Y, Kasali K, Dostbil A. Evaluation of brachial plexus stiffness in different arm and head positions by sonoelastography. Medicine (Baltimore). 2023 Oct 13;102(41):e35559. doi: 10.1097/MD.0000000000035559.
PubMed 37832128
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF BRACHIAL PLEXUS IN DIFFERENT ARM POSITIONS BY ELASTOGRAPHY
- ClinicalTrials.gov ID
- NCT04959058
- Acronym / sponsor ID
- ELAST / B.30.2.ATA.0.01.00/103
- Keywords
- Brachial plexus, Elastography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 13 Jul 2021 (actual)
- 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.
In daily life,people protect their tissues against ischemia by constantly changing positions. In situations that cause unconsciousness such as anesthesia,people cannot react to the stress or pressure due to immobility.This prolongation of immobility can lead to reversible or irreversible damage to the tissues.Therefore,not careful positioning in patients undergoing surgery can lead to serious complications.Peripheral nerve disorders are common in clinical practice.Electrodiagnostic studies continue to be the gold standard for the evaluation of nerve disorders.Elastography is a technique that measures the elastic properties of tissues as a new ultrasonography technology.Given the histological changes in diseased peripheral nerves, nerve elastography has begun to be studied as a noninvasive way to evaluate changes in nerve tissue composition.Elastography of the peripheral nerves has rarely been studied.
Primary aim in this study is to compare the elastography values of the brachial plexus in different arm and head positions and to contribute to elucidating the mechanism of nerve damage due to position.American Society of Anesthesiologists (ASA) I-II volunteers between the ages of 18-65 will be recruited to the study.The bilateral brachial plexus of each volunteer will be examined.Participants with upper extremity or cervical trauma, muscle weakness,cervical disc herniation or a history of spine or cranial surgery, neuromuscular disease, clinical diagnosis of brachial plexopathies, hyperlipidemia,diabetes mellitus or radiotherapy history in the cervical region,body mass index> 35 will not be taken.Before the procedure, the muscle strength of the upper extremity and cervical muscles will be examined and volunteers with muscle weakness will be excluded from the study.Measurements will be made together by two researchers who have at least 5 years of experience in ultrasonography.Measurements will be made in 3 different positions.When the arm and head are in neutral position, the head is turned to the opposite side and the head is turned to the opposite side, the brachial plexus in the supraclavicular region will be visualized by ultrasonography while the arm is in hyperabduction.The area between the upper boundary and the lower boundary of the plexus will be marked, and the values will be taken 5 times consecutively with the share wave elastography method and the elastic modulus,shear wave velocity will be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Measurements will be made in 3 different positions for a participant
| Arm | Type | Receives |
|---|---|---|
| Volunteer | Other | Device: VolunteerThis study has only one arm for the brachial plexus evaluation with ultrasound |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- Volunteers
Key exclusion criteria (12 listed)
- Upper extremity trauma
- Cervical trauma
- Muscle weakness
- Cervical disc herniation
- History of spine surgery
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 |
|---|---|---|
| VolunteerAn ultrasound machine will be used to calculate the elastographic value of the brachial plexus in three different positions. | Device | Volunteer |
Primary outcome
Primary aim in this study is to compare the baseline measurements of elastography values (kPa-kilopascal) of the brachial plexus in different arm and head positions.
Time frame: Prestudy will be conducted with volunteers and the measurement will take about 15 minutes per case for three different case position as described in thestudy will be conducted with volunteers and the measurement will take about 15 minutes per subject.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Derived from this study: PubMed 37832128Karakaya MA, Darcin K, Ince I, Yenigun Y, Kasali K, Dostbil A. Evaluation of brachial plexus stiffness in different arm and head positions by sonoelastography. Medicine (Baltimore). 2023 Oct 13;102(41):e35559. doi: 10.1097/MD.0000000000035559.
- Individual participant dataSharing planned: No
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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.
Ilker Ince principal investigator
Ataturk University, Department of Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer in people with Elasticity Imaging Techniques and Brachial Plexus Injury, run by Ataturk University.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilker Ince, MD (+905052949840, ilkerince1983@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary aim in this study is to compare the baseline measurements of elastography values (kPa-kilopascal) of the brachial plexus in different arm and head positions. (time frame: Prestudy will be conducted with volunteers and the measurement will take about 15 minutes per case for three different case position as described in thestudy will be conducted with volunteers and the measurement will take about 15 minutes per subject.). 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 NCT04959058, which also lists 1 linked publication.
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 16 Jul 2021.