Effect of Ultrasound-guided Insertion on Peripheral Catheters Related Complications.

Not Applicable

• Conditions: Catheter Related Complication
• Interventions: Procedure: Traditional Peripheral venous catheter insertion; Procedure: Ultrasound-guided insertion of a peripheral venous catheter

• Registration Number: NCT05284422
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

The purpose of this study is to compare the appearance of complications after the insertion of peripheral venous catheters with two different techniques (traditional and ultrasound-guided).

Detailed Description

All patients, whose parents were informed about the study and give written informed consent, will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to visualization/palpation or ultrasound-guided peripheral catheter insertion. All participants undergo a 10 days monitoring of the catheter status.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2022-02-14
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-09
• Last Update Submitted: 2022-03-09
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

• Age between 0 and 18 years
• Patients in need of a peripheral venous catheter

Exclusion Criteria

• Inability of insertion in both forearms (i.e. burnt, amputation)
• Patients in need of a central venous catheter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional technique	Traditional Peripheral venous catheter insertion	Peripheral venous catheters inserted to the participants in this arm are inserted with a palpation/visualization guided technique in their hand, arm, foot or head.
Ultrasound-guided technique	Ultrasound-guided insertion of a peripheral venous catheter	Peripheral venous catheters inserted to the participants in this arm are inserted with an ultrasound-guided technique in their forearm.

Primary Outcome Measures

Name	Time	Method
Number of participants presenting peripheral catheter insertion-related complications for each intervention	From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days	Peripheral insertion-related complications: phebitis, infiltration, catheter loss, obstruction

Secondary Outcome Measures

Name	Time	Method
Demographic traits of participants presenting peripheral catheter-related complications	From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days	Age average (years) and gender (male/female)
Use of the catheter inserted in participants presenting peripheral catheter-related complications	From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days	Type of fluid infusion, antibiotic administration (Yes/No)
The proportion of canalization aspects in peripheral catheter-related complications	From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days	Catheter size (Ga), operator experience (years), insertion site (hand/forearm/arm/foot/head), insertion ward (PICU/ER)
Number of participants that present immobilization of the limb in both techniques	From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days	Immobilization of the limb where the peripheral catheter is inserted (Yes/No)

Trial Locations

Locations (1)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain