NCT07013994

Brief Summary

The aim of this clinical trial is to compare the use of ultrasound versus the traditional palpation and visualization technique for vascular punctures, both peripheral venous and arterial punctures for arterial blood gas sampling, in patients presenting to hospital emergency departments. The main questions it seeks to answer are: Does the use of ultrasound facilitate peripheral venous cannulation in patients with difficult venous access in the emergency department? Does the use of ultrasound facilitate arterial puncture in patients presenting to the emergency department who require arterial blood gases? The researchers will compare the use of ultrasound with the traditional technique in vascular punctures by emergency department nurses. To determine the differences in the number of attempts needed, the number of professionals needed to perform the technique, the time invested, the pain produced with both techniques, etc., the researchers will compare the use of ultrasound with the traditional technique for vascular punctures by emergency department nurses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

May 14, 2025

Last Update Submit

April 6, 2026

Conditions

Keywords

UltrasonographyPeripheral venous catheterdifficult venous accessarterial blood pressurenurse

Outcome Measures

Primary Outcomes (5)

  • Scores obtained by DIVA patients on the A-DICAVE scale

    Results of the assessment by the adult patients included in the study using the A-DICAVE scale (Adult Venous Catheterisation Difficulty Scale). With values from 0 to 5. Values greater than or equal to 3 indicate that the patient has difficult venous access.

    At the beginning

  • Scores obtained by DIVA patients on the DIVA scale

    Assessment of paediatric patients using the DIVA scale (Dificil Acceso Vascular). Values above 4 indicate that the patient has a difficult venous access.

    At the beginning

  • Number of patients undergoing successful peripheral venous cannulation

    Successful peripheral venous cannulation using both techniques

    During the intervention, expected time 1 year.

  • Time spent on the techniques to be compared

    Time spent on the techniques from start to completion of the procedure

    During the intervention, expected time 1 year.

  • Number of professionals involved in the technique

    Number of nursing professionals required to perform the technique successfully.

    During the intervention, expected time 1 year.

Secondary Outcomes (2)

  • Pain produced by the techniques

    During the intervention, expected time 1 year.

  • Satisfaction perceived by professionals after performing the techniques

    During the intervention, expected time 1 year.

Study Arms (2)

Echoguided technique

EXPERIMENTAL

Ultrasound will be used for peripheral venous cannulation and arterial puncture by direct visualisation of the needle in the selected structure.

Procedure: peripheral venous cannulation with ultrasound-guided techniqueProcedure: Arterial gas puncture using ultrasound-guided technique

Traditional technique

ACTIVE COMPARATOR

Vascular puncture will be performed using the traditional visualisation/palpation technique.

Procedure: Peripheral venous cannulation with traditional techniqueProcedure: Arterial puncture by traditional technique

Interventions

Peripheral venous cannulation with short peripheral vascular access device, performed by ultrasound technique.

Echoguided technique

Arterial puncture using a needle and heparinised syringe to extract a sample for arterial blood gas analysis, using the ultrasound-guided technique.

Echoguided technique

Cannulation of a short peripheral vascular access device using the traditional visualisation and palpation technique.

Traditional technique

Arterial puncture using a needle and heparinised syringe to extract an arterial blood sample for arterial gamosetry analysis, performed using the traditional arterial pulse palpation technique.

Traditional technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prescription for CIP or GA cannulation.
  • Informed consent signed by the patient or patient's representative.
  • A score ≥3 on the A-DICAVE scale or ≥4 on the DIVA scale for PIVC.

You may not qualify if:

  • Scores below 3 on the A-DICAVE scale or below 4 on the DIVA scale for PIVC.
  • Inability to obtain informed consent from the patient or patient's representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Emergency Department of the Nuestra Señora de Sonsoles Hospital in Ávila.

Ávila, 05004, Spain

Location

Related Publications (15)

  • Romo-Miguel P, Ballesteros-Pena S. Ultrasound-guided puncture vs conventional technique for arterial blood gas analysis sampling in adults: A systematic review. Enferm Intensiva (Engl Ed). 2024 Oct-Dec;35(4):368-375. doi: 10.1016/j.enfie.2023.10.003. Epub 2024 Mar 6.

  • Tran QK, Flanagan K, Fairchild M, Yardi I, Pourmand A. Nurses and Efficacy of Ultrasound-Guided Versus Traditional Venous Access: A Systemic Review and Meta-Analysis. J Emerg Nurs. 2022 Mar;48(2):145-158.e1. doi: 10.1016/j.jen.2021.12.003. Epub 2022 Feb 4.

  • Salleras-Duran L, Fuentes-Pumarola C, Fontova-Almato A, Roqueta-Vall-Llosera M, Camara-Liebana D, Ballester-Ferrando D. Pain and Satisfaction Perceptions of Ultrasound-Guided Versus Conventional Peripheral Intravenous Catheterization: A Randomized Controlled Trial. Pain Manag Nurs. 2024 Feb;25(1):e37-e44. doi: 10.1016/j.pmn.2023.07.010. Epub 2023 Aug 24.

  • Osakidetza. Guía de procedimiento de punción arterial para gasometría en población adulta. 2020. Available on: https://www.researchgate.net/publication/339483856_ guia_de_procedimiento_de_puncion_arterial_para_gasometria_en_poblacion_adulta.

    RESULT
  • Kaganovskaya M, Wuerz L. Development of an educational program using ultrasonography in vascular access for nurse practitioner students. Br J Nurs. 2021 Jan 28;30(2):S34-S42. doi: 10.12968/bjon.2021.30.2.S34.

  • Ocsa C, Gimeno V, Cortés M, Naccarato G, Reinoso G, Nuñez P. Desarrollo de un programa de capacitación en la colocación de catéteres venosos periféricos guiada por ecografía: Experiencia en un hospital pediátrico de tercer nivel. Emerg pediatr. 2024;3(1):44-8.

    RESULT
  • Amick AE, Feinsmith SE, Davis EM, Sell J, Macdonald V, Trinquero P, Moore AG, Gappmeier V, Colton K, Cunningham A, Ford W, Feinglass J, Barsuk JH. Simulation-Based Mastery Learning Improves Ultrasound-Guided Peripheral Intravenous Catheter Insertion Skills of Practicing Nurses. Simul Healthc. 2022 Feb 1;17(1):7-14. doi: 10.1097/SIH.0000000000000545.

  • McKinney A, Steanson K, Lebar K. A Standardized Training Program in Ultrasound-Guided Intravenous Line Placement: Improving Nurses' Confidence and Success. Adv Neonatal Care. 2023 Feb 1;23(1):17-22. doi: 10.1097/ANC.0000000000000969. Epub 2022 Feb 15.

  • Rodriguez-Herrera A, Solaz-Garcia A, Molla-Olmos E, Ferrer-Puchol D, Esteve-Claramunt F, Trujillo-Barbera S, Garcia-Bermejo P, Casana-Mohedo J. Use of the Ultrasound Technique as Compared to the Standard Technique for the Improvement of Venous Cannulation in Patients with Difficult Access. Healthcare (Basel). 2022 Jan 29;10(2):261. doi: 10.3390/healthcare10020261.

  • Lam C, Dunstan L, Sweeny A, Watkins S, George S, Snelling PJ. A survey of paediatric difficult peripheral intravenous access in the emergency department and use of point-of-care ultrasound. Australas J Ultrasound Med. 2023 Jul 13;26(3):184-190. doi: 10.1002/ajum.12353. eCollection 2023 Aug.

  • Pittiruti M, Van Boxtel T, Scoppettuolo G, Carr P, Konstantinou E, Ortiz Miluy G, Lamperti M, Goossens GA, Simcock L, Dupont C, Inwood S, Bertoglio S, Nicholson J, Pinelli F, Pepe G. European recommendations on the proper indication and use of peripheral venous access devices (the ERPIUP consensus): A WoCoVA project. J Vasc Access. 2023 Jan;24(1):165-182. doi: 10.1177/11297298211023274. Epub 2021 Jun 4.

  • Salleras-Duran L, Fuentes-Pumarola C, Ballester-Ferrando D, Congost-Devesa L, Delclos-Rabassa J, Fontova-Almato A. Development, Diagnostic Sensitivity, and Prognostic Accuracy of the Adult-Difficult Venous Catheterization Scale for Emergency Departments. J Emerg Nurs. 2020 Nov;46(6):827-837.e2. doi: 10.1016/j.jen.2020.06.013. Epub 2020 Sep 21.

  • Salleras-Duran L, Fuentes-Pumarola C. [Ultrasound-guided peripheral catheterization]. Enferm Clin. 2016 Sep-Oct;26(5):298-306. doi: 10.1016/j.enfcli.2015.04.002. Epub 2015 Jun 4. Spanish.

  • Genre Grandpierre R, Bobbia X, Muller L, Markarian T, Occean BV, Pommet S, Roger C, Lefrant JY, de la Coussaye JE, Claret PG. Ultrasound guidance in difficult radial artery puncture for blood gas analysis: A prospective, randomized controlled trial. PLoS One. 2019 Mar 20;14(3):e0213683. doi: 10.1371/journal.pone.0213683. eCollection 2019.

  • Rodríguez Calero MA, Miquel Rodríguez Calero CA. Definiendo la vía venosa periférica de difícil canalización y los factores de riesgo asociados. Revisión sistemática Defining the venous peripheral via of difficult canalization and risk factors associated. Sistemic review. Medicina Balear. 2019;34(1):12-2018.

    RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants who meet the inclusion criteria will be randomly selected to form the control group, which will undergo the traditional technique, and the experimental group, which will undergo the study or ultrasound-guided technique.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate in nursing, master's degree in research in nursing sciences.

Study Record Dates

First Submitted

May 14, 2025

First Posted

June 10, 2025

Study Start

August 15, 2025

Primary Completion

January 20, 2026

Study Completion

March 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

It is considered that the individual information of the participants will not be relevant, as the information will consist of the variables that allow the comparison of the techniques under study, and these data will be shared with the results. Sharing more information could only violate the protection of participants' privacy without providing relevant data.

Locations