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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05284422
Enrollment
376
Registered
2022-03-17
Start date
2021-02-01
Completion date
2022-12-31
Last updated
2022-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Related Complication

Keywords

peripheral, ultrasound-guided

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.

Interventions

PROCEDURETraditional Peripheral venous catheter insertion

Insertion of a short catheter in a peripheral vein with the help of visualization palpation

PROCEDUREUltrasound-guided insertion of a peripheral venous catheter

Insertion of a short catheter in a peripheral vein with the help of an ultrasound device

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

A random list is generated by a computer randomizer program. Sealed numbered envelopes are prepared with study documents and the technique to be performed. Investigators take envelops in consecutive order as long as participants accept to be included in the study

Intervention model description

Participants are assigned to the traditional or ultrasound-guided insertion group

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants presenting peripheral catheter insertion-related complications for each interventionFrom catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 daysPeripheral insertion-related complications: phebitis, infiltration, catheter loss, obstruction

Secondary

MeasureTime frameDescription
Demographic traits of participants presenting peripheral catheter-related complicationsFrom catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 daysAge average (years) and gender (male/female)
The proportion of canalization aspects in peripheral catheter-related complicationsFrom catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 daysCatheter 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 techniquesFrom catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 daysImmobilization of the limb where the peripheral catheter is inserted (Yes/No)
Use of the catheter inserted in participants presenting peripheral catheter-related complicationsFrom catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 daysType of fluid infusion, antibiotic administration (Yes/No)

Countries

Spain

Contacts

Primary ContactJesus Corrionero, Nurse
jcorrionero@vhebron.net+34616559445

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026