Ultrasonographic Evaluation of Arteries of the Hand in Pe... | NCT06386718

Studies
Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients

NCT06386718

Sponsor

Ankara University

Status

Recruiting

Last Update Posted

Apr 27, 2025Actual

Enrollment

184Estimated

Phase

Not provided

Conditions

Ulnar and Radial Artery

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2023Actual

Primary Completion Date

May 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Apr 23, 2024

First Submission Date that Met QC Criteria

Apr 23, 2024

First Posted Date

Apr 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2025

Last Update Posted Date

Apr 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Ultrasound measurements of the ulnar artery and radial artery at different angles are obtained and compared to determine the optimal diameters for possible arterial cannulation in pediatric patients.

Detailed Description

Radial artery cannulation is the most commonly used technique for invasive arterial catheterization in pediatric patients. Ultrasound guidance has significantly reduced cannulation success rates and complication risks. The ulnar artery presents an anatomical alternative to the radial artery and has emerged as a potential cannulation site. This study aims to comprehensively evaluate the suitability of the radial or ulnar artery for cannulation in pediatric patients.

Finding of this study objectives are

To obtain a large sample of pediatric patients from different age groups To measure arterial diameters using ultrasound at different angles and with ultrasound and to assess the optimal artery and the angle.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

184Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determining the Diameter and Depth at different angles	The study aims to measure the radial and ulnar arteries using ultrasound at different angles to determine the widest diameter and the optimal angle to achieve this diameter.	only once
Comparing Ulnar and Radial Artery Diameters Across Age Groups	Investigating whether there is a difference (ulnar>radial, ulnar=radial, or radial>ulnar) in the diameter of the ulnar artery compared to the radial artery among the age groups included in the study	only once

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status 1 or 2
Patients scheduled for elective surgical procedures
Informed consent must be obtained from both the patient and, if applicable, their parent or guardian.

Exclusion Criteria:

Patients over 10 years of age
Patients with congenital anomalies or syndromic conditions
Abnormal Allen Test
Skin Erosion or infection at the cannulation site
Hematoma at the cannulation site

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

10 Years

Standard Ages

Child

Study Population

Between 0 and 10 years of ages pediatric patients scheduled for elective surgery under general anesthesia

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ozlem S Can, MD	Contact	+905323107914		ozlemscan@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara University School Of Medicine	Recruiting	Ankara		06100	Turkey (Türkiye)