Central Venous Catheters in Pediatric Anesthesia and Intensive Care (PEDCVC)

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

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.

Study Overview

• Status: Completed
• Conditions: Central Line
• Intervention / Treatment: Device: Central venous line insertion

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 Type: Observational
• Enrollment (Actual): 107

Contacts and Locations

Study Locations

• Czechia
  • State
    • Brno, State, Czechia, 62500
      • University Hospital Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients

Description

Inclusion Criteria:

• Pediatric patients within the age limit indicated for CVC insertion

Exclusion Criteria:

• Outside the age limit

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric patients indicated to CVC insertion; Paediatric patients indicated to central venous line insertion	Device: Central venous line insertion; Pediatric patients indicated to central venous line insertion; Other Names: Central venous line cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brno University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: December 22, 2019
• First Submitted That Met QC Criteria: December 22, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Pediatric patient; Cannulation; Central line; Insertion
• Other Study ID Numbers: KDAR FN Brno 2020/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No