EVALUATION OF BRACHIAL PLEXUS IN DIFFERENT ARM POSITION
ELAST
1 other identifier
interventional
8
0 countries
N/A
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2021
CompletedFirst Posted
Study publicly available on registry
July 13, 2021
CompletedStudy Start
First participant enrolled
July 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedJuly 16, 2021
July 1, 2021
Same day
May 29, 2021
July 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Study Arms (1)
Volunteer
OTHERThis study has only one arm for the brachial plexus evaluation with ultrasound
Interventions
An ultrasound machine will be used to calculate the elastographic value of the brachial plexus in three different positions.
Eligibility Criteria
You may qualify if:
- ASA I-II
- Volunteers
You may not qualify if:
- Upper extremity trauma
- Cervical trauma
- Muscle weakness
- Cervical disc herniation
- History of spine surgery
- Cranial surgery,
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 37832128DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ilker Ince
Ataturk University, Department of Anesthesiology and Reanimation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 29, 2021
First Posted
July 13, 2021
Study Start
July 15, 2021
Primary Completion
July 15, 2021
Study Completion
August 1, 2021
Last Updated
July 16, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share