Central Venous Catheters in Pediatric Anesthesia and Inte... | NCT04211116

Studies
Central Venous Catheters in Pediatric Anesthesia and Intensive Care

NCT04211116

Sponsor

Brno University Hospital

Status

Completed

Last Update Posted

Feb 21, 2021Actual

Enrollment

107Actual

Phase

Not provided

Conditions

Central Line

Interventions

Central venous line insertion

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Feb 15, 2021Actual

First Submitted Date

Dec 22, 2019

First Submission Date that Met QC Criteria

Dec 22, 2019

First Posted Date

Dec 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Petr Štourač, MD, assoc.prof.MD,Ph.D, Brno University HospitalPrincipal Investigator

Lead Sponsor

Brno University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

107Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric patients indicated to CVC insertion		Paediatric patients indicated to central venous line insertion	Device: Central venous line insertion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Central venous line insertion	Device	Pediatric patients indicated to central venous line insertion	Pediatric patients indicated to CVC insertion

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients within the age limit indicated for CVC insertion

Exclusion Criteria:

Outside the age limit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Pediatric patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Brno		Brno	State	62500	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided