Effect of Ultrasound-guided Insertion of Peripheral Catheters in the Forearm in Complications Incidence.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 376
- Locations
- 1
- Primary Endpoint
- Number of participants presenting peripheral catheter insertion-related complications for each intervention
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, 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
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: Traditional Peripheral venous catheter insertion (Procedure)
Ultrasound-guided technique
Peripheral venous catheters inserted to the participants in this arm are inserted with an ultrasound-guided technique in their forearm.
Intervention: Ultrasound-guided insertion of a peripheral venous catheter (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)