Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion

Two Different Techniques for Ultrasound Guided Peripheral Venous Catheter Insertion in Pre-hospital Emergency Care - Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Prehospital
• Intervention / Treatment: Procedure: Full utrasound guidance; Procedure: Partial ultrasound guidance; Procedure: No ultrasound guidance

Detailed Description

Peripheral venous catheter placement is one of the most common interventions in emergency medicine. When performed by conventional approach, the failure of the first attempt occurs up to 22 % and cannulation time exceed 2 minutes in up to 15 %. Ultrasound guidance of peripheral venous catheter (PVC) insertion may improve both. However, this approach has not been verified in the setting of pre-hospital emergency care so far.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Central Bohemian Region
    • Beroun, Central Bohemian Region, Czechia
      • Emergency Medical Service of the Central Bohemian Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Coma
2. Age <18 years
3. Patient disagreement with the insertion of peripheral venous catheter
4. Disagreement of the patient with inclusion in a clinical trial
5. Contraindication of ultrasound examination of the venous system
6. Contraindication of the introduction of peripheral venous cannula on both upper limbs
7. Investigator's opinion that ultrasonic control cannulation would cause undue delay and a other procedure is required

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: Full utrasound guidance; 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; 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
Active Comparator: Group B: Partial ultrasound guidance; 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; The target vein is directly identified by ultrasound but the procedure of peripheral venous cathether insertion is performed conventionally, without ultrasound guidance
Active Comparator: Group C: No ultrasound guidance; Catheter insertion by conventional approach, without ultrasound guidance	Procedure: No ultrasound guidance; The target vein is identified and peripheral venous catheter is inserted by conventional approach without use of any guiding devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of the patients with successful peripheral venous catheter insertion irrespective of the number of attempts	Frequency of the patients in which peripheral venous catheter was inserted, irrespective of the number of attempts	60 minutes
The number of attempts required for successful peripheral venous catheter insertion	The number of attempts required for successful peripheral venous catheter insertion	60 minutes
Time required to introduce peripheral venous catheter	Time required to introduce peripheral venous catheter	60 minutes

Collaborators and Investigators

• Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Collaborators: Masaryk Hospital Usti nad Labem
• Investigators: Principal Investigator: Roman Skulec, MD, PhD, Emergency Medical Service of Central Bohemian Region, Kladno, Czech republic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound; peripheral venous catheter
• Other Study ID Numbers: 2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Completely anonymous sharing of IPD
• IPD Sharing Time Frame: 1.5.2018, two months
• IPD Sharing Access Criteria: investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No