RecruitingACTRN12623000426684

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)


Sponsor

Royal Women's Hospital

Enrollment

25 participants

Start Date

Jun 6, 2023

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 1 Years

Plain Language Summary

Simplified for easier understanding

When critically ill newborns need fluids or medications urgently, doctors insert thin tubes called central venous catheters into their veins. Getting the tip of the tube placed correctly is crucial, but checking the position can take time. This study is exploring whether signals from a heart monitor (ECG) recorded through the catheter itself can reliably tell doctors where the tip is — potentially making procedures faster, safer, and less stressful for vulnerable babies. The NeoNav ECHO Study uses a specially designed device to record electrical signals through the catheter while it is being placed or in use. Ultrasound (echocardiography) is then used to confirm where the tip actually sits. Researchers will compare these measurements to see if the ECG signals accurately predict catheter position. This study is open to newborns admitted to the Neonatal Intensive Care Unit at the Royal Women's Hospital who already need a central line as part of their care. Parents or guardians will be asked for consent. The study does not add extra procedures beyond what is already planned — it simply records additional data during and after routine catheter placement.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 sm

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.


Locations(1)

The Royal Women's Hospital - Parkville

VIC, Australia

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ACTRN12623000426684