Pre-hospital Ultrasound Guided Peripheral Venous Catheter Insertion

NCT ID: NCT03709394

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-03-31

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.

Conditions

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Prehospital

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Full utrasound guidance

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Partial ultrasound guidance

Intervention Type PROCEDURE

The target vein is directly identified by ultrasound but the procedure of peripheral venous cathether insertion is performed conventionally, without ultrasound guidance

Group C: No ultrasound guidance

Catheter insertion by conventional approach, without ultrasound guidance

Group Type ACTIVE_COMPARATOR

No ultrasound guidance

Intervention Type PROCEDURE

The target vein is identified and peripheral venous catheter is inserted by conventional approach without use of any guiding devices

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

No ultrasound guidance

The target vein is identified and peripheral venous catheter is inserted by conventional approach without use of any guiding devices

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masaryk Hospital Usti nad Labem

OTHER

Sponsor Role collaborator

Emergency Medical Service of the Central Bohemian Region, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Roman Skulec

Head physician for science and research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roman Skulec, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emergency Medical Service of Central Bohemian Region, Kladno, Czech republic

Locations

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Emergency Medical Service of the Central Bohemian Region

Beroun, Central Bohemia, Czechia

Site Status

Countries

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Czechia

Other Identifiers

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2017-01

Identifier Type: -

Identifier Source: org_study_id

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