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Static Ultrasound Guidance for Radial Arterial Puncture (STATIC-US)

28. mai 2026 oppdatert av: adem melekoğlu, Sisli Hamidiye Etfal Training and Research Hospital

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

    • Kağıthane
      • Istanbul, Kağıthane, Tyrkia (Türkiye), 34413
        • Adem Melekoglu, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Aktiv komparator: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Puncture Duration
Tidsramme: Immediately after the procedure
Immediately after the procedure
Puncture Duration
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
First-Attempt Success Rate
Tidsramme: During the procedure
Successful radial arterial puncture achieved on the first needle insertion attempt.
During the procedure

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Score
Tidsramme: 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

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. april 2023

Primær fullføring (Faktiske)

5. mai 2023

Studiet fullført (Faktiske)

5. juni 2023

Datoer for studieregistrering

Først innsendt

21. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • SHEAH-ED-2026-001
  • 3870 (Annen identifikator: Sisli Hamidiye Etfal Clinical Research Ethics Committee)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data are not planned to be shared because of institutional data protection policies and patient confidentiality considerations.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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