Ultrasonography For Radial Artery Diameter Measurement And Its Correlation With Allen Test

March 12, 2018 updated by: Guniz M.Koksal, Istanbul University

Radial Artery Diameter Measurement By Ultrasonography For Determination Of Proper Cannula Size And Investigation Of Correlation Between Allen Test And Doppler Ultrasonography

In this study, the investigators will investigate how patients' radial artery diameters change according to sex, age, height, weight and body mass index by measuring radial artery diameter using ultrasonography. The correlation of Allen test with doppler ultrasonography will also be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Arterial catheterization for continuous hemodynamic monitoring or frequent blood sampling is a common procedure in anesthesia and critical care setting. The most commonly used site for arterial catheterization is the radial artery because of its superficial course, alternate blood supply to hand via ulnar artery and a low rate of complications. Allen test is a simple, but not reliable, method for assessing the safety of radial artery catheterization. Intraarterial catheterization has some complications such as hematoma, vasospasm, arterial thrombosis, necrosis of skin overlying. Using larger size cannula from radial artery diameter, increase rate of complications. The purpose of this study is to investigate the corelation of radial artery diameter with sex, age, height, weight and body mass index for determination of proper cannula size and investigation of correlation between Allen test and doppler ultrasonography.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Istanbul University Cerrahpasa Medical Faculty
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients will be operated under general anesthesia
  • patients were American Society of Anesthesiology (ASA) physical status I or II

Exclusion Criteria:

  • ASA III, IV, V
  • History of coroner artery disease
  • History of peripheral artery disease,
  • History of diabetes mellitus,
  • History of hypertension
  • Hemodynamic instability
  • Hypovolemia
  • History of Reynaud phenomenon
  • History of hand or arm trauma
  • previous catheterization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: All patients
Other: Allen test
Before induction, with firm occlusive pressure held on both the radial and ulnar arteries, the patient is asked to clench his or her fist several times until the palmar skin is blanched. The patient is then instructed to unclench the fist, and then ulnar artery pressure is released while maintaining occlusion of the radial artery. Overextension of the hand and wide spreading of the fingers should be avoided because it can lead to falsely abnormal results. The time required for palmar capillary refill is noted. An abnormal Allen test result was defined as a recovery time of more than 10 seconds.
Other: Radial artery diameter measurement by ultrasonography
Ultrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned. The diameter of the radial artery will be measured and recorded.
Other: Ulnar artery doppler ultrasonography
Ultrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the ulnar arter will be scanned. The blood fow of ulnar artery will be measured and recorded.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change of the radial artery diameter according to sex, age, height, weight and body mass index
Time Frame: 5 minutes prior to anesthesia induction
Ultrasonography measurements will be performed with a linear probe. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degree with a wrist pad. The Ultrasonography probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned. The diameter of the radial artery will be measured and recorded.
5 minutes prior to anesthesia induction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
correlation between Allen test and doppler ultrasonography.
Time Frame: 5 minutes prior to anesthesia induction
Before induction, with firm occlusive pressure held on both the radial and ulnar arteries, the patient is asked to clench his or her fist several seconds until the palmar skin is blanched. The patient is then instructed to unclench the fist, and then ulnar artery pressure is released while maintaining occlusion of the radial artery. The time required for palmar capillary refill is noted. An abnormal Allen test result was defined as a recovery time of more than 10 seconds. Ultrasonography measurements will be performed with a linear probe. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degree with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the ulnar artery will be scanned. The blood fow of ulnar artery will be measured and recorded.
5 minutes prior to anesthesia induction
change of the radial artery diameter according to sex, age, height, weight and body mass index after the induction
Time Frame: 5 minutes following to anesthesia induction
Ultrasonography measurements will be performed with a linear probe. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degree with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial arter will be scanned. The diameter of the radial artery will be measured and recorded.
5 minutes following to anesthesia induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Güniz Meyancı Köksal, Prof., Istanbul University Cerrahpasa Medical Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 419999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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