- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Kağıthane
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Istanbul, Kağıthane, Turchia (Türkiye), 34413
- Adem Melekoglu, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Puncture Duration
Lasso di tempo: Immediately after the procedure
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Immediately after the procedure
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Puncture Duration
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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First-Attempt Success Rate
Lasso di tempo: During the procedure
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Successful radial arterial puncture achieved on the first needle insertion attempt.
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During the procedure
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pain Score
Lasso di tempo: Immediately after completion of the arterial puncture procedure
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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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Collaboratori e investigatori
Pubblicazioni e link utili
Collegamenti utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- SHEAH-ED-2026-001
- 3870 (Altro identificatore: Sisli Hamidiye Etfal Clinical Research Ethics Committee)
Piano per i dati dei singoli partecipanti (IPD)
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