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.

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.

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 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.

Doctor's Day 2021

The 30th of March is National Doctors’ Day; a day that celebrates the impact physicians around the world have on people lives. 

As a medical device company that is driven by a vision of giving children brighter, healthier futures, we have a deep awareness and appreciation for the incredible work doctors do. We are also privileged to work alongside some passionate physicians who have helped us on our journey, and who we would like to show some appreciation and recognition on this day.

We have chosen three doctors that we’d like to highlight for this special day.

One such doctor is our very own Chief Medical Officer, A/Prof Christiane Theda, who has dedicated over 30 years of her life caring for critically-ill newborns.

Christiane is currently a senior Neonatal Consultant at the Royal Women’s Hospital, as well as co-founder of Navi. She leads our clinical studies which support the development of the Neonav ECG Tip Location System, a device that will provide clinicians with real-time feedback on the location of the catheter tip across a number of procedures.

A/Professor Christiane Theda pictured beside a clinical prototype of the Neonav

Whilst dedicating a huge part of her life to Neonatal medicine, she did not really know what area of medicine she wanted to focus on when she commenced her medical studies;

“I had not “planned” to become a neonatologist. During my studies, my thoughts were to become a specialist in sport medicine, radiology or neurology.” 

However, a chance encounter with a young 8-year-old patient during her rotations in paediatrics as a student caused her to consider helping children as an area of focus.

“When I had my first workday in the NICU (neonatal intensive care unit), I went home thinking: Neonatology is it, the NICU is the place I am going to spend the rest of my professional life”.

Having worked as a clinician around the world in Germany, the USA as well as Australia, Christiane is focused and driven by one simple yet powerful guiding principle,

“[It’s] very simple – and maybe it sounds a bit cliché: help the babies and their families!”

And it is this guiding principle that drives Dr. Theda not only as a doctor, but also as an entrepreneur and inventor.

“New technologies offer so many opportunities to innovate; if it is software and data processing or other amazing new engineering developments, I feel that there is “a lot out there” in regard to advances and technology that will contribute to improved care for critically ill newborns and children”.

Another doctor that Navi has worked with closely in development of the Neonav is A/Professor Andreas Pflaumer.

Originally from Munich, Germany, Dr. Pflaumer is a Paediatric Cardiologist with a sub-specialty interest in electrophysiology. He holds an honorary appointment at the MCRI Murdoch Children’s Research Institute), and sits on Navi’s Advisory Panel as a key clinical advisor. 

A/Prof Andreas Pflaumer.

Source: rch.org.au

His journey to becoming a doctor was one driven by impact;

“I did my internship 30 years ago in Germany. At that time Electrophysiology was not an established field of practice. During my internship, I was impressed how children deal with disease and how much potential for change there was with the right treatment.”

This observation led him to focus on helping children as a paediatrician, which ultimately led him towards his speciality in cardiology;

“During my time as paediatrician, I learned that cardiac disease and neural disease have the most severe impact on a child’s early life”.

Whilst there are significant challenges and stresses that Dr. Pflaumer faces as a paediatric cardiologist, it is the outcomes that really drive him,

“Working in a very technical field, it is important to keep the balance between the technical possibilities, the potential risks of a treatment and the benefits for the child while still providing the best care. While this can be very difficult, the reward of a seeing a previously sick child thriving is always worth it.”

Looking forward, Dr. Pflaumer is most excited for the digital transformation of the health industry and the introduction of new technologies to help ease administrative burden that comes with it;

“The digital transformation of the health industry is the most exciting, though also the most challenging development. In the past 20 years, technology dramatically changed the way we understand and treat heart disease.”

“This first step of digitalisation though burdens all health care workers with administrative tasks and reduces the time we spend with the patients and their families. I hope that the further development of machine-learning and artificial intelligence will reverse this development and allow not only a more effective, but also a more personal and patient centred medicine.”

Another inspiring doctor and good friend of the Navi team is Dr Mardi Steere, who is currently Executive General Manager for Medical & Retrieval Services at the Royal Flying Doctors Service (Central Operations). Dr. Steere also has a strong driving passion for the development of universal health coverage for the underserved, especially for countries and communities with limited access to health care, and has provided some valuable insight to the Navi team on the challenges of delivering effective care to sick children in regional and Low-Middle Income Countries.

Pictured: Dr. Mardi Steere . Source: Royal Flying Doctors Service

“After completing my postgrad Paeds Emergency training in the US, I and my husband (a civil engineering projects manager) really felt convicted that we have been given so much that we needed to give back. We moved to Kenya with our kids in 2011 to serve in a Christian mission hospital - we planned to go for 2 years initially and ended up staying for 8.”

Living and working with her dedicated and professional Kenyan colleagues gave Dr. Steere life changing perspective of healthcare.

“We are incredibly fortunate to live in a wealthy country in Australia that views healthcare as a right & prioritises funding it.”

In her current role at the Royal Flying Doctors Service, Dr. Steere is facilitating equitable healthcare access for rural, regional and remote Australians.

“It is simply unacceptable that urban Australians have some of the best health outcomes in the world; while our most remote communities have outcomes on par with LMIC’s (Low-and-Middle Income Countries).”

“Comprehensive healthcare access should be available in this day and age to all Australians, no matter where you live.”

What most excites Dr. Steere about the future of medicine are the possibilities brought on by innovation, 

“There has never been a greater time to innovate - in telehealth; in new approaches to chronic disease management; in nanotechnology to miniaturise diagnostic equipment & therapeutics; in creative approaches to healthcare delivery. If we can improve how to better care for isolated communities in Australia, the broader applications for other countries could also be astronomical”

“Wouldn’t it be amazing to make a real difference for our own population that also happens to have a global impact?”

There’s an inspirational thread that links Dr. Theda, Dr. Pflaumer, and Dr. Steere; despite the challenges they face in their respective fields, they are all focused on their patients first and foremost, and optimistic about the role technology can play in improving standards of care.

The team at Navi would like to thank Dr. Theda, Dr. Pflaumer and Sr. Steere, as well as doctors globally who dedicate their lives to helping others.