- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07625631
Static Ultrasound Guidance for Radial Arterial Puncture (STATIC-US)
Static Ultrasound-Guided Versus Conventional Palpation Techniques for Radial Arterial Puncture in the Emergency Department: A Randomized Controlled Trial
Radial arterial puncture is a commonly performed procedure in emergency departments for arterial blood gas analysis and invasive hemodynamic monitoring. The conventional palpation technique may be associated with prolonged procedure duration and multiple puncture attempts, particularly in patients with weak arterial pulsation or difficult vascular anatomy.
Ultrasound guidance has been proposed as a method to improve procedural success. This randomized controlled trial aimed to compare the static ultrasound-guided technique with the conventional palpation technique for radial arterial puncture in adult emergency department patients.
The primary outcome was puncture duration. Secondary outcomes included first-attempt success rate, total number of attempts, procedure-related complications, and patient pain scores.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Radial arterial puncture is frequently performed in emergency departments for arterial blood gas sampling and invasive arterial pressure monitoring. Although the conventional palpation technique is widely used, procedural failure, prolonged puncture duration, and repeated attempts remain common problems, especially in patients with difficult vascular access.
Ultrasound-guided vascular access techniques have demonstrated improved success rates in several vascular procedures. However, evidence regarding the effectiveness of the static ultrasound-guided method for radial arterial puncture in emergency department settings remains limited.
This prospective randomized controlled trial was conducted in the emergency department of University of Health Sciences, Sisli Hamidiye Etfal Training and Research Hospital. Adult patients requiring radial arterial puncture were randomly assigned to either the static ultrasound-guided group or the conventional palpation group.
In the static ultrasound-guided group, the radial artery location was identified using ultrasonography prior to skin puncture, and the puncture site was marked externally. In the conventional group, arterial puncture was performed using anatomical landmarks and palpation alone.
The primary outcome of the study was puncture duration. Secondary outcomes included first-attempt success, total number of puncture attempts, procedure-related complications, and patient-reported pain scores.
The study aimed to evaluate whether the static ultrasound-guided technique could improve procedural efficiency and success compared with the conventional palpation technique in emergency department practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kağıthane
-
Istanbul, Kağıthane, Turkey (Türkiye), 34413
- Adem Melekoglu, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18 years and older
- Patients requiring radial arterial puncture in the emergency department
- Patients who provided informed consent
Exclusion Criteria:
- Patients younger than 18 years
- Known vascular abnormalities or previous vascular surgery involving the puncture site
- Local infection or skin lesion at the puncture site
- Hemodynamic instability requiring immediate intervention
- Inability to provide informed consent
- Previous enrollment in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Static Ultrasound-Guided Group
Participants underwent radial arterial puncture using the static ultrasound-guided technique.
The radial artery was identified with ultrasonography prior to puncture, and the puncture site was externally marked before needle insertion.
|
Static ultrasound guidance was used to identify and externally mark the radial artery location prior to arterial puncture.
|
|
Active Comparator: Conventional Palpation Group
Participants underwent radial arterial puncture using the conventional palpation technique based on anatomical landmarks and arterial pulse palpation.
|
Radial arterial puncture was performed using anatomical landmarks and palpation without ultrasound guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Puncture Duration
Time Frame: Immediately after the procedure
|
Immediately after the procedure
|
|
|
Puncture Duration
Time Frame: At completion of the arterial puncture procedure or after a maximum of three puncture attempts
|
Time required to successfully complete radial arterial puncture, measured from skin contact of the needle to successful arterial blood aspiration.
|
At completion of the arterial puncture procedure or after a maximum of three puncture attempts
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-Attempt Success Rate
Time Frame: During the procedure
|
Successful radial arterial puncture achieved on the first needle insertion attempt.
|
During the procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Score
Time Frame: Immediately after completion of the arterial puncture procedure
|
Patient-reported procedural pain measured immediately after arterial puncture using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
Immediately after completion of the arterial puncture procedure
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SHEAH-ED-2026-001
- 3870 (Other Identifier: Sisli Hamidiye Etfal Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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