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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623000426684
Acronym
NeoNav ECHO study
Enrollment
16
Registered
2023-04-28
Start date
2023-06-06
Completion date
2025-12-31
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Royal Women's Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
0 to 1 Years
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026