Central Venous Catheters in Pediatric Anesthesia and Intensive Care

NCT ID: NCT04211116

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 107 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-02-15

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.

Conditions

Central Line

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric patients indicated to CVC insertion

Paediatric patients indicated to central venous line insertion

Central venous line insertion

Intervention Type: DEVICE

Pediatric patients indicated to central venous line insertion

Interventions

Central venous line insertion

Pediatric patients indicated to central venous line insertion

Intervention Type: DEVICE

Other Intervention Names

Central venous line cannulation

Eligibility Criteria

Inclusion Criteria

• Pediatric patients within the age limit indicated for CVC insertion

Exclusion Criteria

• Outside the age limit

• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

assoc.prof.MD,Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Brno

Brno, State, Czechia

Countries

Czechia

Other Identifiers

KDAR FN Brno 2020/1

Identifier Type: -

Identifier Source: org_study_id