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OpenTrials
Completed

NCT Number: NCT04211116

Central Venous Catheters in Pediatric Anesthesia and Intensive Care

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.

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Key information

Conditions

Central Line

Age range

Up to 19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Brno

Brno, State, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients within the age limit indicated for CVC insertion

Exclusion criteria

  • Outside the age limit

Treatment and study plan

Central venous line insertion

Device

Pediatric patients indicated to central venous line insertion

Other names: Central venous line cannulation

Primary outcomes

  1. Overall success and first attempt success rate

    Time frame: During CVC insertion

    The overall success rate and first attempt success rate will be evaluated between ultrasound-guided and anatomical-based navigation

Secondary outcomes

  1. Incidence of complications

    Time frame: 24 hours from CVC insertion

    Incidence of arterial puncture, hemothorax and/or pneumothorax incidence, incidence of CVC malposition will be recorded

  2. Time of insertion

    Time frame: During CVC insertion

    The time from first percutaneous puncture to CVC insertion will be monitored and evaluated between

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

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

Acronym: PEDCVC

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 26, 2019
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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