Validating the effectiveness of hyperbaric oxygen therapy with TcpO2

https://www.linkedin.com/in/denys-katz-70029b182/

Perimed

The development of hyperbaric oxygen therapy (HBOT) reflects a journey of scientific discovery and clinical innovation spanning several centuries. The pioneering work of physicians like François Junod in the 1800s and Dr. Ite Boerema in the 1900s established the medical foundations of HBOT and cemented its use in clinical practice.

As a fan of the renowned French explorer Jacques Cousteau, I would say that even if his impact wasn’t clinical, his widespread influence generated significant awareness about the benefit of hyperbaric chambers

In the US, the FDA has cleared hyperbaric chambers for 13 medical uses, to treat conditions like decompression sickness, carbon monoxide poisoning, and nonhealing wounds such as diabetic foot ulcers (DFUs). But HBOT is used for a much wider variety of conditions (than on the FDA list) including traumatic brain injury (TBI), fibromyalgia, chronic fatigue syndrome, PTSD, and by the beauty industry as an anti-aging therapy. Research, like the current study at the Karolinska Institute in Stockholm on the use of HBOT to treat Long Covid [1] is also widespread.

Against the backdrop of growing demand, I’ve written this post to highlight the role of TcpO2 in HBOT and how this measurement can help clinicians determine a patient’s eligibility for HBOT as well as assess the treatment’s effectiveness throughout its course.

Growing demand

Estimates for the HBOT device market predict that the sector will more or less double between the years 2022 and 2030 — with wound healing being the dominant application. The growth reflects factors like aging populations, rising incidence of DFUs, and new application areas that will generate significant demand for HBOT chambers and expertise — with a corresponding financial burden on healthcare systems.

A person undergoing hyperbaric oxygen therapy sits or lies down in a pressurized chamber and breathes pure oxygen at (or above) 2ATA (twice the atmospheric pressure exerted at sea level). The idea is to increase the amount of oxygen in the blood, which in turn promotes healing and recovery. A session typically lasts about 90 minutes and patients often require multiple sessions depending on what they are being treated for — 60+ for some conditions (Hyperbaric Center of Lille).

To meet the growing demand and validate the effectiveness of HBOT, some insurance companies are beginning to require diagnostic assessments before approving treatment (eligibility tests). As the success of HBOT often depends on raising oxygen levels in the patient’s tissue, TcpO2 has emerged as an effective way to do this kind of eligibility test because it measures the local pressure of oxygen released through the skin. And you don’t need a hyperbaric chamber to carry out this initial measurement, you can perform an oxygen challenge with TcpO2 in any clinic — assuming you have a measurement device.

Oxygen challenge with TcpO2

TcpO2 is a noninvasive diagnostic exam that emerged in clinical devices in the late 1970s, made possible through Clark-type electrodes that can measure the local pressure of oxygen released through the skin from the capillaries. As a measurement technique, TcpO2 offers several advantages:  it is noninvasive, does not require clinical staff to administer contrast agents, and patients don’t need to fast.

After taking a baseline TcpO2 measurement, an oxygen challenge is performed during which the patient breathes pure oxygen at standard pressure (sea level), and another TcpO2 measurement is recorded. While there isn’t a one-size-fits-all set of TcpO2 thresholds that can predict how well a patient will respond to HBOT, in their study [2], Fife et. al, uncovered several insights — depending on the condition of the patient. One of their findings shows normal people always have a TcpO2 oxygen challenge value above 100 mmHg, so we can expect hyperbaric oxygen therapy to be beneficial for anyone with similar oxygen-challenge levels. Different reference values may apply to patients with conditions like diabetic foot, for example — always refer to local best practice guidelines.

Continued assessment of treatment effectiveness

As a repeatable and comparable measurement, TcpO2 provides an additional layer of insight on top of other forms of treatment effectiveness assessment, such as visual observation of the wound healing process, or cognitive capability tests following a TBI.

You can carry out TcpO2 measurements at any time during a course of treatment — before, during, and after an HBOT session. The repeatability factor ensures you can rely on TcpO2 to assess how patients respond to treatment over time.

While some work has been done to develop threshold values for HBOT effectiveness, by nature, any findings are specific to the underlying conditions of the patient. For example, in a retrospective analysis of people with diabetes who underwent hyperbaric oxygen therapy for lower extremity wounds, the researchers found that:

“TcPO2 measured in chamber provides the best single discriminator between success and failure of hyperbaric oxygen therapy using a cutoff score of 200 mmHg.” [3]

Our contribution

In addition to healing, one of the success points of HBOT in my mind has much to do with its noninvasive nature. TcpO2 is also noninvasive and a pain-free experience. These characteristics are not only key for patient comfort they enable clinicians to prep patients and take measurements efficiently, and in a patient-centric way.

We’ve designed our TcpO2 solutions with this crucial aspect of patient-centric care in mind. Delivered on a cart, our system is easily maneuverable and automatically measures TcpO2 once the patient is prepped. Results are delivered in a comprehensive report that can be transferred to any patient management system via DICOM.

Our solutions can measure patients inside and outside the hyperbaric chamber — be it mono- or multi-space — to deliver pre-, during-, and post-treatment measurements.

Meet me at EUBS 2024

I will shortly head up to EUBS, 2024 in Brest to demonstrate the flexibility of PeriFlux 6000 and how easy it is to prep patients and measure their TcpO2 values. I will bring our remote panels too so that you can see how in-chamber measurement works. Do drop by if you are attending. Do drop by if you are attending EUBS 2024.

In the meantime, if you want to find out more about our TcpO2 solutions and in-chamber remote panels, take a look at our page on hyperbaric oxygen.

 

References

[1] Kjellberg A, Douglas J, Pawlik MT, et al Randomised, controlled, open label, multicentre clinical trial to explore safety and efficacy of hyperbaric oxygen for preventing ICU admission, morbidity and mortality in adult patients with COVID-19 BMJ Open 2021;11:e046738. https://bmjopen.bmj.com/content/11/7/e046738

[2] Fife, C. E., Smart, D. R., Sheffield, P. J., Hopf, H. W., Hawkins, G., & Clarke, D. (2009). Transcutaneous oximetry in clinical practice: consensus statements from an expert panel based on evidence. Undersea & hyperbaric medicine: journal of the Undersea and Hyperbaric Medical Society, Inc, 36(1), 43–53.

[3] Fife, C.E., Buyukcakir, C., Otto, G.H., Sheffield, P.J., Warriner, R.A., III, Love, T.L. and Mader, J. (2002), The predictive value of transcutaneous oxygen tension measurement in diabetic lower extremity ulcers treated with hyperbaric oxygen therapy: a retrospective analysis of 1144 patients. Wound Repair and Regeneration, 10: 198-207. https://doi.org/10.1046/j.1524-475X.2002.10402.x

 

Disclaimer:
The views and opinions expressed in this blog post are solely those of the author and do not necessarily reflect the official position or policies of Perimed. The content provided here is intended for informational purposes only and should not be interpreted as clinical claims or medical advice. Readers should consult healthcare professionals for specific medical concerns or treatment options.