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

March 9, 2022 updated by: Hospital Universitari Vall d'Hebron Research Institute

Effect of Ultrasound-guided Insertion of Peripheral Catheters in the Forearm in Complications Incidence.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

376

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Vall d'Hebron
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional technique
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.
Procedure: Traditional Peripheral venous catheter insertion
Insertion of a short catheter in a peripheral vein with the help of visualization palpation
Experimental: Ultrasound-guided technique
Peripheral venous catheters inserted to the participants in this arm are inserted with an ultrasound-guided technique in their forearm.
Procedure: Ultrasound-guided insertion of a peripheral venous catheter
Insertion of a short catheter in a peripheral vein with the help of an ultrasound device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants presenting peripheral catheter insertion-related complications for each intervention
Time Frame: 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
From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic traits of participants presenting peripheral catheter-related complications
Time Frame: From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
Age average (years) and gender (male/female)
From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
The proportion of canalization aspects in peripheral catheter-related complications
Time Frame: 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)
From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
Number of participants that present immobilization of the limb in both techniques
Time Frame: 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)
From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days
Use of the catheter inserted in participants presenting peripheral catheter-related complications
Time Frame: 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)
From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR(AMI)24/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The name and location (ward/room) of participants will be accessible to researchers until the peripheral catheter withdrawal.

IPD Sharing Time Frame

From the insertion to the withdrawal of the peripheral venous catheter.

IPD Sharing Access Criteria

Investigator will access individual participant data to monitor and register the catheter condition

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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