Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion

• Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03709394
• Collaborator: Masaryk Hospital Usti nad Labem (Other)
• Enrollment: 300
• Location: 1
• Arms: 3
• Actual Duration (Months): 26.9
• Patients Per Site Per Month: 11.1

Study Details

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	N/A

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
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective randomized studyProspective 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: Jan 1, 2017
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: Mar 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 [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 [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 [60 minutes]

   The number of attempts required for successful peripheral venous catheter insertion

3. Time required to introduce peripheral venous catheter [60 minutes]

   Time required to introduce peripheral venous catheter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 17, 2018
• Last Update Posted: Jul 21, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Roman Skulec, Head physician for science and research, Emergency Medical Service of the Central Bohemian Region, Czech Republic: ultrasound; peripheral venous catheter

Study Results

No Results Posted as of Jul 21, 2020