Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion

• ClinicalTrials.gov Identifier: NCT03709394
• Recruitment Status: Completed
• First Posted: October 17, 2018
• Last Update Posted: July 21, 2020
• Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Collaborator: Masaryk Hospital Usti nad Labem
• Information provided by (Responsible Party): Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prehospital	Procedure: Full utrasound guidance; Procedure: Partial ultrasound guidance; Procedure: No ultrasound guidance	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Two Different Techniques for Ultrasound Guided Peripheral Venous Catheter Insertion in Pre-hospital Emergency Care - Randomized Study
• Actual Study Start Date: January 1, 2017
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: March 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Frequency of the patients with successful the first cannulation attempt of peripheral venous catheter insertion [ Time Frame: 60 minutes ]
   Frequency of the patients in which only one cannulation attempt was necessary

Secondary Outcome Measures :

1. Frequency of the patients with successful peripheral venous catheter insertion irrespective of the number of attempts [ Time Frame: 60 minutes ]
   Frequency of the patients in which peripheral venous catheter was inserted, irrespective of the number of attempts
2. The number of attempts required for successful peripheral venous catheter insertion [ Time Frame: 60 minutes ]
   The number of attempts required for successful peripheral venous catheter insertion
3. Time required to introduce peripheral venous catheter [ Time Frame: 60 minutes ]
   Time required to introduce peripheral venous catheter

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Czechia

Emergency Medical Service of the Central Bohemian Region

Beroun, Central Bohemian Region, Czechia

Sponsors and Collaborators

Emergency Medical Service of the Central Bohemian Region, Czech Republic

Masaryk Hospital Usti nad Labem

Investigators

• Principal Investigator: Roman Skulec, MD, PhD; Emergency Medical Service of Central Bohemian Region, Kladno, Czech republic

More Information

• Responsible Party: Roman Skulec, Head physician for science and research, Emergency Medical Service of the Central Bohemian Region, Czech Republic
• ClinicalTrials.gov Identifier: NCT03709394
• Other Study ID Numbers: 2017-01
• First Posted: October 17, 2018
• Last Update Posted: July 21, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Completely anonymous sharing of IPD
• Supporting Materials: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: 1.5.2018, two months
• Access Criteria: investigator

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic:

ultrasound; peripheral venous catheter