NCT04959058

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Status
unknown

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

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

Same day

First QC Date

May 29, 2021

Last Update Submit

July 12, 2021

Conditions

Keywords

Brachial plexus, Elastography

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

OTHER

This study has only one arm for the brachial plexus evaluation with ultrasound

Device: Volunteer

Interventions

VolunteerDEVICE

An ultrasound machine will be used to calculate the elastographic value of the brachial plexus in three different positions.

Volunteer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Study Officials

  • Ilker Ince

    Ataturk University, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet Muhammet Karakaya, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Measurements will be made in 3 different positions for a participant
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