Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prehospital

Intervention / Treatment
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* Procedure: Full utrasound guidance
* Procedure: Partial ultrasound guidance
* Procedure: No ultrasound guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Awake patient indicated for peripheral venous catheter placement while treated by emergency medical service Exclusion Criteria: Coma Age <18 years Patient disagreement with the insertion of peripheral venous catheter Disagreement of the patient with inclusion in a clinical trial 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized study
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, peripheral venous catheter