Central Venous Catheters in Pediatric Anesthesia and Intensive Care

Central Line Clinical Trial

— PEDCVC  

Official title:

Central Venous Catheters in Pediatric Anesthesia and Intensive Care: Prospective Observational Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211116
• Other study ID #: KDAR FN Brno 2020/1
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: February 2021
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Securing the intravenous line is one of the fundamental interventions in paediatric anaesthesia and intensive care. Central venous catheters (CVC) are indicated for long-term stay in intensive care unit (ICU), in case of circulatory instability and the need for vasopressor therapy, for hypertonic solutions administration and parenteral nutrition. The dominant method of CVC insertions is the Seldingers´ method (over the wire) and ultrasound real-time navigation in recommended. Ultrasound-guided (USG) CVC insertion however requires experience personnel and relevant training.This could be the main reason, that CVC the real-time ultrasound navigation is still not adequately implemented into the clinical practice.

Description:

After Ethics committee approval, patients indicated for CVC insertions will be included. Based on the observational design of the trial, the method of insertion (Real-time ultrasound navigation versus anatomical-based CVC insertion) will be based on operators´ decision.The indication for CVC insertion, primary planned site of insertion, USG implementation, site of actual CVC cannulation and associated complications will be recorded. The primary aim of the study was to compare the effectivity of Real-time ultrasound navigation versus anatomical-based CVC insertion in paediatric patients and the 1st percutaneous puncture success rate. The secondary aims will be the incidence of associated complications and the time form first percutaneous puncture, to definitely securing the CVC in place. The primary hypothesis is that the Ultrasound-guided CVC insertion is superior, with the higher overall success, higher first attempt success rate and with lower incidence of associated complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 15, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

Inclusion Criteria:

• Pediatric patients within the age limit indicated for CVC insertion

Exclusion Criteria:

• Outside the age limit

Related Conditions & MeSH terms

• Central Line

Intervention

Device:
• Central venous line insertion
Pediatric patients indicated to central venous line insertion

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno	State

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall success and first attempt success rate	The overall success rate and first attempt success rate will be evaluated between ultrasound-guided and anatomical-based navigation	During CVC insertion
Secondary	Incidence of complications	Incidence of arterial puncture, hemothorax and/or pneumothorax incidence, incidence of CVC malposition will be recorded	24 hours from CVC insertion
Secondary	Time of insertion	The time from first percutaneous puncture to CVC insertion will be monitored and evaluated between	During CVC insertion