Trial Review

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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
16/06/2023
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] 309021 0
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 329069 0
Condition category
Condition code
Reproductive Health and Childbirth 326048 326048 0 0
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] 325465 0
Early Detection / Screening
Comparator / control treatment
The comparator is the catheter tip position as per ultrasound.
Control group
Active

Outcomes
Primary outcome [1] 333909 0
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] 333909 0
At completion of intravascular electrocardiogram and ultrasound recordings
Secondary outcome [1] 418715 0
Nil
Timepoint [1] 418715 0
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?
No
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
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24073 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 39581 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 313231 0
Government body
Name [1] 313231 0
Victorian Medical Research Acceleration Fund Grant
Country [1] 313231 0
Australia
Funding source category [2] 313232 0
Commercial sector/Industry
Name [2] 313232 0
Navi Medical Technologies Pty Ltd
Country [2] 313232 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
20 Flemington Road
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 314958 0
None
Name [1] 314958 0
Address [1] 314958 0
Country [1] 314958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312461 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 312461 0
20 Flemington Road
Parkville VIC 3052
Ethics committee country [1] 312461 0
Australia
Date submitted for ethics approval [1] 312461 0
05/07/2022
Approval date [1] 312461 0
23/05/2023
Ethics approval number [1] 312461 0

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 124750 0
A/Prof Christiane Theda
Address 124750 0
Royal Women's Hospital
Neonatal Services
20 Flemington Road
Parkville VIC 3052
Country 124750 0
Australia
Phone 124750 0
+61 3 8345 2671
Fax 124750 0
Email 124750 0
Christiane.Theda@thewomens.org.au
Contact person for public queries
Name 124751 0
A/Prof Christiane Theda
Address 124751 0
Royal Women's Hospital
Neonatal Services
20 Flemington Road
Parkville VIC 3052
Country 124751 0
Australia
Phone 124751 0
+61 3 8345 2671
Fax 124751 0
Email 124751 0
Christiane.Theda@thewomens.org.au
Contact person for scientific queries
Name 124752 0
A/Prof Christiane Theda
Address 124752 0
Royal Women's Hospital
Neonatal Services
20 Flemington Road
Parkville VIC 3052
Country 124752 0
Australia
Phone 124752 0
+61 3 8345 2671
Fax 124752 0
Email 124752 0
Christiane.Theda@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
19463Ethical 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
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