- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kağıthane
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Istanbul, Kağıthane, Turquía (Türkiye), 34413
- Adem Melekoglu, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
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Static ultrasound guidance was used to identify and externally mark the radial artery location prior to arterial puncture.
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Comparador activo: Conventional Palpation Group
Participants underwent radial arterial puncture using the conventional palpation technique based on anatomical landmarks and arterial pulse palpation.
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Radial arterial puncture was performed using anatomical landmarks and palpation without ultrasound guidance
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Puncture Duration
Periodo de tiempo: Immediately after the procedure
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Immediately after the procedure
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Puncture Duration
Periodo de tiempo: At completion of the arterial puncture procedure or after a maximum of three puncture attempts
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Time required to successfully complete radial arterial puncture, measured from skin contact of the needle to successful arterial blood aspiration.
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At completion of the arterial puncture procedure or after a maximum of three puncture attempts
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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First-Attempt Success Rate
Periodo de tiempo: During the procedure
|
Successful radial arterial puncture achieved on the first needle insertion attempt.
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During the procedure
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain Score
Periodo de tiempo: 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.
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Immediately after completion of the arterial puncture procedure
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- SHEAH-ED-2026-001
- 3870 (Otro identificador: Sisli Hamidiye Etfal Clinical Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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