ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000426684

Ethics application status

Approved

Date submitted

17/02/2023

Date registered

28/04/2023

Date last updated

1/09/2024

Date data sharing statement initially provided

28/04/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

NeoNav ECHO Study: Determine what electrocardiogram (ECG) waveforms are associated with central venous access lines placed in babies and checked by ultrasound

Scientific title

NeoNav ECHO Study: Electrocardiogram (ECG) waveforms associated with central venous catheter tip position (of catheters placed in babies) as verified by echocardiography (ECHO)

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1288-6229

Trial acronym

NeoNav ECHO study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Newborn Vascular Access

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Neonatal patients requiring central venous catheters will be recruited. The procedure itself will be performed as per usual clinical practice with only one minor adjustment, i.e. the placement of a small adapter between syringe and catheter hub that allows for detection of intravascular ECG (IV-ECG) signals through the saline solution. With informed consent, the IV-ECG will be recorded for analysis to determine characteristic IV-ECG features as they related to catheter tip position as determined by imaging. An ultrasound (echocardiogram, ECHO) will be performed immediately after insertion to determine the location of the catheter tip within the participants vascular system. Repeat recordings and ultrasound tip determination will be repeated daily until the catheter is removed as per decision of the clinical team. Both the IV-ECG recoding and ECHO will only take a few minutes (<10 min) each. While the clinician performing the procedure will place the adapter, the IV-ECG recording will be performed by the research team and a neonatologist certified in ultrasonography (who is part of the research team) will perform the ultrasound. While the focus of this observational trial is to define how intravascular ECG features correlate with a specific catheter tip positions on imaging, we like to note that a new ECG device (only available for use in this trial and used under TGA Clinical Trials Notification) is used to record intravascular and surface ECGs. As the procedure is being performed as per usual practice and without changes or interventions, this new device is only used in an observational manner. Daily recordings will be performed and the removal of the catheter will be determined by the clinical team, thus the number of recordings per participant will vary according to indwelling time of the catheter.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

The comparator is the catheter tip position as per ultrasound.

Control group

Active

Outcomes

Primary outcome [1]

Electrocardiogram (ECG) characteristics for different catheter tip positions including placement in the preferred position (at the junction of the inferior vena cava and the atrium), too far advanced in (reaching into the atrium or further into the heart or superior vena cava), or too low (in the ductus venosus or liver vessels).

Timepoint [1]

At completion of intravascular electrocardiogram and ultrasound recordings

Secondary outcome [1]

Nil

Timepoint [1]

N/A

Eligibility

Key inclusion criteria

Neonatal inpatients at the Royal Women's Hospital Neonatal Intensive Care Unit requiring central venous catheter (CVC) placement or arriving at the RWH with a CVC in place AND clinical team approves approach of family for consent

Minimum age

0 Days

Maximum age

1 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Emergency catheterisation procedures. Assesment by clinical team that patient is too unstable to perform the recording. Infusions which do not allow connection of an adapter and related small saline flush.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Multiple statistical analyses will be performed to correlate various combinations of ECG waveforms and characteristics with catheter tip location scores, Due to dependence between a number of variables, fitting of linear mixed models will be used. Analysis will be performed with advice of and under supervision of a qualified statistician.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

17/05/2023

Actual

6/06/2023

Date of last participant enrolment

Anticipated

30/06/2025

Actual

Date of last data collection

Anticipated

30/06/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Victorian Medical Research Acceleration Fund Grant

Address [1]

State of Victoria
Department of Jobs, Precincts and Regions
121 Exhibition Street
Melbourne VIC 3000

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Navi Medical Technologies Pty Ltd

Address [2]

Melbourne Connect
700 Swanston Street
Melbourne VIC 3052

Country [2]

Australia

Primary sponsor type

Hospital

Name

Royal Women's Hospital

Address

20 Flemington Road
Parkville VIC 3052

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

20 Flemington Road
Parkville VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/07/2022

Approval date [1]

23/05/2023

Ethics approval number [1]

Summary

Brief summary

Safe vascular access is essential for treatment of critically ill newborns. The NeoNav ECHO Study investigates electrocardiographic (ECG) signals measured through catheters placed as part of clinical care and checks if these signals can reliably determine where the tip is located as checked on ultrasound.  This knowledge will contribute to develop a new device that doctors and nurses can use while placing these catheters to increase success rates of the procedures and make them faster and less stressful for babies.
The research team will approach potential participants to offer study participation and obtain consent. When consent is given, the Neonav device (provided by Navi Medical Technologies Pty Ltd and used under TGA Clinical Trials Notification) will be used to record intravascular ECG traces through the catheter during the catheter insertion, daily spot checks post-insertion and at removal of the catheter. Echocardiography will be done to determine where the catheter tip is located. Analyses will determine if and how ECG waveform characteristics compare to the position of the catheter tip as determined by ultrasound.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Christiane Theda

Address

Royal Women's Hospital
Neonatal Services
20 Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 8345 2671

Fax

Christiane.Theda@thewomens.org.au

Contact person for public queries

Name

Christiane Theda

Address

Royal Women's Hospital
Neonatal Services
20 Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 8345 2671

Fax

Christiane.Theda@thewomens.org.au

Contact person for scientific queries

Name

Christiane Theda

Address

Royal Women's Hospital
Neonatal Services
20 Flemington Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 8345 2671

Fax

Christiane.Theda@thewomens.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

The investigators are not willing to support a general data sharing agreement/access as default. We are aware that there are some entities who might use such data access for commercial purposes. If data access requests were made by research teams for clinical or academic reasons, we would potentially consider data sharing.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
19463	Ethical approval					385423-(Uploaded-31-05-2023-16-33-24)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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