Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion

NCT03709394 | Completed

• 1 other identifier: 2017-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates two different techniques for ultrasound guided peripheral venous catheter insertion in pre-hospital emergency care in comparison with conventional approach without any ultrasound guidance.

Conditions

Prehospital

Keywords

ultrasound; peripheral venous catheter

Outcome Measures

Primary Outcomes (1)

• Frequency of the patients with successful the first cannulation attempt of peripheral venous catheter insertion

  Frequency of the patients in which only one cannulation attempt was necessary

  60 minutes

Secondary Outcomes (3)

• Frequency of the patients with successful peripheral venous catheter insertion irrespective of the number of attempts

  60 minutes

• The number of attempts required for successful peripheral venous catheter insertion

  60 minutes

• Time required to introduce peripheral venous catheter

  60 minutes

Study Arms (3)

Group A: Full utrasound guidance

ACTIVE COMPARATOR

Full utrasound guidance of cathether insertion. Intervention: Ultrasound portable device used for the identification of the target vein and for the ultrasound control of proper catheter placement during the procedure of peripheral venous cannula insertion.

Procedure: Full utrasound guidance

Group B: Partial ultrasound guidance

ACTIVE COMPARATOR

Catheter insertion under partial ultrasound guidance. Intervention: Ultrasound portable device used only for the identification of the target vein, the catheter placement will be done by conventional approach.

Procedure: Partial ultrasound guidance

Group C: No ultrasound guidance

ACTIVE COMPARATOR

Catheter insertion by conventional approach, without ultrasound guidance

Procedure: No ultrasound guidance

Interventions

Full utrasound guidance PROCEDURE

The target vein is directly identified by portable ultrasound device and the complete procedure of peripheral venous cathether insertion is controlled by ultrasound guidance in real time

Group A: Full utrasound guidance

Partial ultrasound guidance PROCEDURE

The target vein is directly identified by ultrasound but the procedure of peripheral venous cathether insertion is performed conventionally, without ultrasound guidance

Group B: Partial ultrasound guidance

No ultrasound guidance PROCEDURE

The target vein is identified and peripheral venous catheter is inserted by conventional approach without use of any guiding devices

Group C: No ultrasound guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Awake patient indicated for peripheral venous catheter placement while treated by emergency medical service

You may not qualify if:

• Coma
• Age \<18 years
• Patient disagreement with the insertion of peripheral venous catheter
• Contraindication of ultrasound examination of the venous system
• Contraindication of the introduction of peripheral venous cannula on both upper limbs
• Investigator's opinion that ultrasonic control cannulation would cause undue delay and a other procedure is required

Sponsors & Collaborators

• Emergency Medical Service of the Central Bohemian Region, Czech Republic: lead
• Masaryk Hospital Usti nad Labem: collaborator

Study Sites (1)

Emergency Medical Service of the Central Bohemian Region

Beroun, Central Bohemia, Czechia

Location

Study Officials

• Roman Skulec, MD, PhD

  Emergency Medical Service of Central Bohemian Region, Kladno, Czech republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head physician for science and research

Model Details: Prospective randomized study

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: October 17, 2018
• Study Start: January 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: March 31, 2019
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1.5.2018, two months
• Access Criteria: investigator

Locations

CZ (1)