picc line

The Rise Of Catheter Tip Surveillance

Central catheter placements in critically-ill children is a relatively common surgical procedure. However, once the catheter enters the patients blood vessel, it is an unknown where the catheter tip ends up during the procedure. For clinicians, this lack of easily accessible, real-time feedback is one the challenging aspects of performing these procedures. Currently, the most common method of confirming the catheter tip location is the use of x-ray, but only after the procedure has taken place. The result - around 40% of catheters are misplaced during the insertion procedure, often requiring clinicians to repeat the procedure that ultimately delays treatment to critically-ill newborn and pediatric patients.

Pictured: Premature newborn in a NICU with an Umbilical Venous Catheter inserted

The problem doesn’t stop there. After the initial placement location has been confirmed, the dwell time (the time the catheter remains inside the patient) can be up to 30 days in some central catheters such as Peripherally Inserted Central Catheters (PICC’s). During this time, the catheter can move or “migrate” from a safe location to other areas in the body, which can have a significant on impact treatment, or cause serious harm to the patient. What’s most concerning is the frequency these migration events can occur, with recent studies showing up to 50% of correctly placed catheters migrate within 7 days.

For example, a correctly placed catheter in the Inferior Vena Cava (a high blood flow vessel area located just below the heart) could migrate away from the safe position over several days and end up in the heart. This can cause a number of complications such as cardiac tamponade, where fluid builds up in the space around the heart that can ultimately extend patient hospital stay, or worse, could be fatal.

Animation example of catheter migrations and related complications

While ECG Tip Location Technologies have been developed in recent years to help with the catheter placement problem, current technologies primarily focus on the adult population, and only focus on the initial placement of the catheter while mostly ignoring the migration issue.

90% of catheters had migrated from their position on the preceding scan
— Hoellering A et. al.

Shing Yue Sheung, Navi COO and Biomedical Engineer, knows all too well the current limitations of existing ECG Tip Location Systems,

“Most ECG Tip Location Systems on the market today have limited capabilities when dealing with the pediatric cohort, especially premature newborns. Speaking with neonatologists and clinical staff from around the world, it had become clear to the Navi team that catheter migration was a big problem, possibly bigger than misplacement on insertion, and that it needed a solution.”

There is growing evidence that supports the need for a technology that can provide clinicians with surveillance capabilities of the catheter during its dwell time. Migration, and the subsequent complications that follow, lead to poor patient outcomes as well as increased costs to hospitals.

A 2018 study by Hoellering A et. al.1 identified that migration prevalence in a neonatal cohort of patients was staggaringly high, showing “90% of catheters had migrated from their position on the preceding scan” after correct initial insertion.

Another recent paper in 2021 by Acun, C et al.2 highlighted that “catheter migration is the most common complication in neonates”, recommending periodic imaging during the first 3 days after PICC insertion (as most migration occurred within this period).

Explainer Video On How The Neonav ECG Tip Location System will help with catheter misplacement and surveillance

Navi’s Neonav® ECG Tip Location System, which is currently in development, will address this gap in catheter surveillance, by developing a device that not only is specifically designed for critically-ill newborn and pediatric patients, but also will provide clinical staff with a comprehensive means of catheter tip surveillance - from initial insertion right through its dwell time. This will enable faster treatment, reduced complications, improved hospital efficiencies and reduced costs, ultimately leading to better patient outcomes, and enabling children everywhere to live brighter, healthier futures.

  1. Hoellering, Adam et al. “Study of movement of umbilical venous catheters over time.” Journal of paediatrics and child health vol. 54,12 (2018): 1329-1335. doi:10.1111/jpc.14073

  2. Acun, C., Baker, A., Brown, L. S., Iglesia, K. A., & Sisman, J. (2021). Peripherally inserted central catheter migration in neonates: Incidence, timing and risk factors. Journal of Neonatal-Perinatal Medicine, (Preprint), 1-7.

2021 - A Year In Review

From restrictions, to lockdowns, to the general fog of uncertainty, this past year has presented a number of challenges that required all businesses to embrace change.

Despite these pandemic challenges, the team at Navi made significant progress towards our vision of giving children brighter, healthier futures through medical innovations. Below are some of the 2021 highlights:  

Expanded Our Clinical Activities

Lockdowns and restrictions brought on by the COVID-19 pandemic had a significant impact on clinical activities, with hospitals taking precautionary measures that included halting clinical research for a period of time.

Pictured: The Neonav® clinical prototype used during the Navi feasibility study and the Royal Women’s Hospital in Melbourne, Australia.

Pictured: Mubin Yousuf and A/Prof Christiane Theda at the Royal Women’s Hospital in Melbourne, Australia.

Despite this setback, our research team, headed by Navi Chief Medical Officer A/Prof Christiane Theda and CTO Mubin Yousuf, made some significant progress on our clinical research activities.

The Neonav® feasibility study, which involves the use of the Neonav® clinical prototype device to record real-world patient data, is in its final stages. To date, over 120 patients have been recruited across multiple studies that cover both Umbilical Venous Catheterisation (UVC) and Peripherally Inserted Central Catheter (PICC) procedures, with hundreds of data points being logged and incorporated into our proprietary location detection algorithm technology.

Local & Global Recognition

Navi’s work on the Neonav® Tip Location System had received attention both domestically and abroad this year, which included significant media exposure, as well as participation in a number of high profile events:

Parliamentary Recognition

A highlight was the Navi team receiving recognition from Federal Minister Karen Andrews, who made a notable mention of Navi as a leading example of next generation of innovative healthcare businesses as part of her address to parliament.

National News Coverage

The work Navi has been doing was also featured on Channel 7 News, where Navi CEO Alex Newton was interviewed as part of a prime time news segment that shared some patient stories and successes from our clinical research at The Royal Women's Hospital.

Additionally, the Herald Sun included a feature article that focused on the real-life impact the Neonav® has had during its clinical study at the Royal Women’s Hospital.

Presented At The Association For Vascular Accesses (AVA) In The USA

Across the pacific in the United States, Navi Chief Medical Officer A/Prof Christiane Theda and CEO Alex Newton presented (virtually) at this year’s Association For Vascular Access (AVA) conference.

AVA is a leading multidisciplinary community that seeks to advance research to bring about evidence-based innovations in vascular access. At the conference, both Alex and Christiane shared the results of the recent Neonav® clinical studies surrounding the Electrocardiogram (ECG) Waveforms Associated with Central Venous and Arterial Catheterisations in Neonates.

Participated on a global stage

Navi also participated in some of the worlds largest pitch competitions and accelerators in 2021:

Both the XTC and the MedTech Innovator programs provided a global platform to introduce our technology to a broader audience, and receive valuable feedback and validation to help drive further progress. 

Grants and funding

Navi was successful in a number of grants during 2021, with notable wins including the Victorian Government’s Victorian Technology Adoption & Innovation Program (TAIP) grant. This grant provided important financial support towards core product development activities, but also provided significant media exposure that launched Navi into the national spotlight.

Additionally, Navi was also awarded the Federal Government’s Entrepreneurs program – growth grant, which helped support key business development activities.

Navi also finished up the Accelerating Commercialisation Grant project, which was awarded by the Federal Government, and provided matched funding to support important product development and clinical milestones during the 2021 period.

Significant Product Development Milestones

This year brought further advancement in the Neonav® development, with significant progress made on both the Neonav® capital hardware, as well as the consumable componentry that form a core part of the Neonav’s ecosystem. Both aspects of product development have been progressed to advanced stages of the design process.

This video explains how the Neonav® ECG Tip Location System works, as well as its benefits compared to the current standard of care:.

Increased Accuracy

Preliminary testing of the Neonav® algorithm with real-world procedural data collected from our ongoing clinical studies achieved an accuracy of over 93% for catheter tip location detection for UVC procedures. This result is extremely encouraging, and is a strong indictor that greater accuracy is to be expected as more data is collected and the technology matures over the coming 12 months.

“[The Neonav®] achieved an accuracy of over 93% for catheter tip location detection for UVC procedures.”

Moved into our new home

This year also saw the Navi team move to our new home at Melbourne Connect, which is a purpose-built innovation precinct right in the heart of the city’s Biomedical precinct, and is a powerhouse innovation and collaboration in Melbourne.

We are grateful to be a part of such an amazing, inspiring community of emerging thinkers and leaders in Melbourne.

Growing the Navi family

The latest member of the Navi family was welcomed in October 2021, with the birth of Oliver “Ollie” Newton, Navi CEO Alex Newton’s second child.

Navi commences PICC lines study at the Royal Women’s Hospital

Navi has taken another big step in the development of the Neonav ECG Tip Location Device, expanding the existing research study at the Royal Women’s Hospital’s Newborn Intensive Care Unit (NICU) to investigate Neonav’s application in the placement of PICCs in newborns.

Pictured left to right: Navi CTO Mubin Yousuf and Navi CMO (Medical) Dr. Christiane Theda at the commencement of the PICC study at the Royal Women’s Hospital in Melbourne, Australia.

Pictured left to right: Navi CTO Mubin Yousuf and Navi CMO (Medical) Dr. Christiane Theda at the commencement of the PICC study at the Royal Women’s Hospital in Melbourne, Australia.

Navi’s Chief Medical Officer, Christiane Theda, is leading the expanded study and is excited about what can be learnt through this research.

“The expansion of our study at the Women’s means we will be able to work towards our goal to significantly improve the procedures newborn babies have to undergo to provide them potentially lifesaving vascular access to give fluids, medications and intravascular nutrition,” said Christiane.

“This new phase of our study is an important further step towards safer care for critically ill children.”

Globally, it is estimated that there are over 2 million PICC insertion procedures performed in newborn and pediatric patients, with up to 50% experiencing instances of misplacement or migration due to lack of real-time confirmation technologies available.

According to Mubin Yousuf, Navi’s CTO and the person managing the development of the software that powers the Neonav, this study will help broaden Neonav’s ability to identify catheter tip locations during PICC procedures, and ultimately reduce instances of misplacement.

“We have been able to significantly improve Neonav’s software using the learnings and the data collected from our previous studies,” said Mubin.

The Neonav clinical prototype being used during a PICC line insertion procedure as part of the Neonav observational study in the Royal Women’s Hospital - Melbourne, Australia

The Neonav clinical prototype being used during a PICC line insertion procedure as part of the Neonav observational study in the Royal Women’s Hospital - Melbourne, Australia

“The focus now is to apply these learnings to collect new data and expand the software’s capability to allow for accurate placement and migration detection of PICCs.”

The expanded research study into PICC procedures has been funded in part by the Victorian Governments Medical Research Accelerating Fund (VMRAF), and is conducted in partnership with, and incredible support from, the Women’s.