Central Venous Catheters in Pediatric Anesthesia and Intensive Care

Completed

• Conditions: Central Line
• Interventions: Device: Central venous line insertion

• Registration Number: NCT04211116
• Lead Sponsor: Brno University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-22
• Study First Submitted QC: 2019-12-22
• Study First Posted: 2019-12-26
• Study Start: 2020-03-01
• Primary Completion: 2020-12-31
• Status Verified: 2021-02
• Study Completion: 2021-02-15
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Pediatric patients within the age limit indicated for CVC insertion

Exclusion Criteria

• Outside the age limit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric patients indicated to CVC insertion	Central venous line insertion	Paediatric patients indicated to central venous line insertion

Primary Outcome Measures

Name	Time	Method
Overall success and first attempt success rate	During CVC insertion	The overall success rate and first attempt success rate will be evaluated between ultrasound-guided and anatomical-based navigation

Secondary Outcome Measures

Name	Time	Method
Incidence of complications	24 hours from CVC insertion	Incidence of arterial puncture, hemothorax and/or pneumothorax incidence, incidence of CVC malposition will be recorded
Time of insertion	During CVC insertion	The time from first percutaneous puncture to CVC insertion will be monitored and evaluated between

Trial Locations

Locations (1)

University Hospital Brno; 🇨🇿 Brno, State, Czechia