Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion

Prehospital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03709394
• Other study ID #: 2017-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: July 2020
• Source: Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 31, 2019
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prehospital

Intervention

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
• 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
• No ultrasound guidance
The target vein is identified and peripheral venous catheter is inserted by conventional approach without use of any guiding devices

Locations

Country	Name	City	State
Czechia	Emergency Medical Service of the Central Bohemian Region	Beroun	Central Bohemian Region

Sponsors (2)

Lead Sponsor	Collaborator
Emergency Medical Service of the Central Bohemian Region, Czech Republic	Masaryk Hospital Usti nad Labem

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The number of attempts required for successful peripheral venous catheter insertion	The number of attempts required for successful peripheral venous catheter insertion	60 minutes
Secondary	Time required to introduce peripheral venous catheter	Time required to introduce peripheral venous catheter	60 minutes