NCT04211116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

December 22, 2019

Last Update Submit

February 18, 2021

Conditions

Central Line

Keywords

Central linePediatric patientInsertionCannulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Incidence of complications

    24 hours from CVC insertion

  • Time of insertion

    During CVC insertion

Study Arms (1)

Pediatric patients indicated to CVC insertion

Paediatric patients indicated to central venous line insertion

Device: Central venous line insertion

Interventions

Central venous line insertionDEVICE

Pediatric patients indicated to central venous line insertion

Also known as: Central venous line cannulation
Pediatric patients indicated to CVC insertion

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients

You may qualify if:

  • Pediatric patients within the age limit indicated for CVC insertion

You may not qualify if:

  • Outside the age limit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Brno

Brno, State, 62500, Czechia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc.prof.MD,Ph.D

Study Record Dates

First Submitted

December 22, 2019

First Posted

December 26, 2019

Study Start

March 1, 2020

Primary Completion

December 31, 2020

Study Completion

February 15, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

CZ(1)