RT talks to two humidification manufacturers about the latest industry trends

This month’s Market Analysis Q&A asked executives from two humidification device manufacturers to look at the trends that will carry the industry forward, as well as what manufacturers need to focus on to meet the needs of the health care industry.

Our respondents include Tom Miller, PhD, director of clinical research and education at Vapotherm Inc, Stevensville, Md; and Hal Norris, founder and president of ARC Medical Inc, Tucker, Ga.

RT: What are the latest technological trends in your segment of the humidification market that are key to meeting the needs of RTs?

Tom Miller: The latest technological trends in our segment are twofold. First, there are the additions of adjunctive therapies, such as drug delivery and specialty gases, etc, that can be coupled with the humidification devices. This allows the respiratory therapist to meet and/or refine multiple treatment objectives without interruption of optimized respiratory gas delivery. Furthermore, integrated therapeutic devices simplify the job, making more efficient use of the therapist’s time.

A second trend in humidification therapy is home care applications. Newer advances in conditioning and energy state preservation for respiratory gases are facilitating better humidification in home-based products. I foresee these advances resulting in opportunities to transition patients to the home sooner and with better care. An understanding of the value in the technology behind home care respiratory support translates to an understanding of the value of respiratory therapists, who will no doubt emerge as more critical decision makers in care beyond the hospital.

Hal Norris: One of the things that has changed recently is low tidal volume ventilation and how therapists are using it. This has the benefit of making moisture exchangers much more efficient because the total minute ventilation is reduced. Heat and moisture exchangers (HMEs) are dependent on minute ventilation in order to function properly, so a device that doesn’t function well at high minute ventilations will not perform as intended

Our main products are designed for patients where the potential for high minute ventilation is necessary. Our humidification efficiencies, even at 20 liter minute ventilation, are above the AARC Clinical Practice Guidelines.

Our standard ThermoFlo™ devices have been very successful in trauma care and in ICUs of large institutions like Orlando Regional Medical Center. Our customers use ThermoFlo from intubation to extubation and have for more than 18 years. For millions of ventilator patient days, ThermoFlo has been used from intubation to extubation without a single report of tube occlusion or pneumothorax.

RT: Tell us about your company’s most recent humidification products and why they are innovative.

Miller: This is a very exciting time for Vapotherm because we are launching our line of products for High Flow Therapy (HFT) aimed at the subacute and home care environment. Conditioning respiratory gas is in reality no small feat, and technology for humidification in the hospital has depended to a large extent on such things as the availability of pressurized gas and expensive technology for temperature control and feedback systems. We have developed a new platform suitable for home care and lower acuity settings. This new platform, Flowrest®, uses self-contained blowers for flow generation, plus adapted membrane and patent-pending circuit technology to achieve ideal gas conditioning and energy state preservation. Now HFT can be used in low-acuity settings for treating hypoxia and dyspnea, as well as a humidification therapy.

Norris: [Given that] we are seeing people using low minute ventilation, we designed a product called the ThermoFlo Midi. The Midi still meets the same standards for a heat moisture exchanger at 10 liter minute ventilation. Our standard product will meet the minimum standards at 20 liter minute ventilation. So for those institutions using low tidal volume minute ventilation or long-term acute care, the Midi product is really designed for them. When patients are stabilized and are going to be on a ventilator long term, the Midi product works better.

One of the innovations we did several years ago was what we call the Secretion Solution. Our device collects secretions next to the patient so that the secretions that are a result of therapy end up accumulating on the patient side, minimizing the risk of the device becoming occluded. If the filter of our device does become covered with secretions, then the filter will break through and protect the patient from a pneumothorax. The circuit may be contaminated and alarms will alert the therapist that the device has been compromised.

RT: What key trend do you think will carry humidification technology forward in the next 5 years?

Miller: I believe that the technology that will carry humidification therapy forward in the next 5 years is membrane technology. Membrane technology overcomes the major limitations in both conventional and other novel humidification concepts, and has yet to be expanded into most areas of respiratory care. Conventional passover humidifiers are complex in that they must boil water to a vapor state, balancing vaporization with flow rates. Then, with regard to temperature management, algorithms and feedback systems are needed to balance cooling times and maintenance heaters to get the gas to a correct temperature in time to reach the patients. As a result, these devices are known for “rainout,” which has become par for the course in respiratory care.

With humidification membrane technology, a pore size is used that allows water to pass through in a monomolecular form, so rather than overheat the water, true vapor-phase humidification is imparted to the gas. Therefore, the water needs only to be heated to the correct, ideal temperature, and membrane surface area can easily be determined to allow the water to warm the gas to this ideal temperature. Thus, the conditioned gas emerges as saturated with vapor and at the precise temperature desired, therefore downstream energy management systems need only be something as simple as a jacketed tube; ie, no need to readjust or “fine tune” the gas temperature with complex feedback and heater systems.

One further advantage of the membrane technology is the packaging. The systems can be relatively small and they are robust. To this latter point, conventional humidifiers are limited as to the pressure they can be exposed to, whereas the larger plastic humidifier domes experience relatively high wall stress when exposed to various respiratory system circuit pressures. While outlets for respiratory gas in the hospital units are typically pressurized at 45–50 psi, conventional humidifiers need to be on the downstream, or patient, side of a respiratory device. With the more robust packaging of membrane technology, there are more options as to where humidification can take place, and what types of environments it can be used in.

Norris: Currently, we are working on two separate projects that will take the technology forward. However, I am unable to comment on them at this time.

RT: Given the rising costs of health care and the tighter budgets health care facilities are forced to work with, how are manufacturers helping health care providers adopt new advanced technologies and ensuring that there is a meaningful return on their investment?

Miller: Technology continues to drive us in the direction of minimally invasive support by optimizing the delivery of a therapy through better understanding of provider needs and underlying physiology. The best route to adoption is continuing education.

Vapotherm has put a great deal of effort into developing and/or supporting programs for education and communication among our clinical development team and the caregivers who use our products. We’ve created the Vapotherm Education Centers where we have supported independent, qualified persons to create online courses discussing important topics in respiratory care. These topics range from interpreting research, to technical information, to documenting the value of a respiratory care department. We have also supported, via an educational grant, the development of HighFlow.org, which is an online community of practice, allowing therapists to share needs and concerns as well as treatment paradigms and practice guidelines. The nature of this bona fide education on both how new technologies work and how they are best implemented serves a critical role in adoption and maximizing return on investment.

Norris: ThermoFlo is the most cost-effective way of providing humidification. There are less expensive, ineffective ways to do it; and there are certainly ways that are more expensive. The key factor is the per day cost of an HME. The difference between an effective HME and a poor performing HME may be no more than 20 or 30 cents a day. And what you get for that is insurance, a performance record of no endotracheal tube occlusions, which is safer for the patient.

Even though we have been doing this for 21 years and our market has grown substantially, there is still a lot of bad information about HME devices. One of the problems with the studies and the quotes about HMEs is they just say an HME was used, not which HME. It’s like saying a car was used in a race. If you do not know the performance of the device, then you cannot judge the outcome. Most of the studies were done without using modern devices, like ThermoFlo. ARC Medical is looking for someone to publish a study comparing our HME to any heated wire system, heated water bath system, or HME device used daily—and will help [support] that study. This study would provide the answer on whether a high performing HME device that avoids under-humidification and is incapable of over-humidification can reduce VAP rates. We have anecdotal evidence that this occurs, but it needs to be done in a documented way.

RT: What markets or health care settings exhibit the best opportunity for growth in humidification product sales?

Miller: The health care setting that exhibits the best opportunity for growth is home care. Movement of humidification technology to the home care front addresses the concerns of rising health care costs, and also fosters realignment with the current trends in care. Over the last 20 years, we have seen a dramatic reduction in hospital beds, despite the more than double per capita health care spending in this period. Patients are moving home, and care needs to follow. I see this as an opportunity not just for manufacturers, but for therapists as well. As the technologies that the RT commands in the hospital are remodeled for home use, I see this presenting the RT with a bigger role in deciding on the paradigm of home care.

What does this means for humidification therapy? For starters, oxygen cannulae that don’t irritate the nose; sleeping through the night on apnea therapy and not waking with a dry mouth; use of insufflation-based ventilatory support therapies at home; daily humidification treatment for mucus and mucociliary function. This is just the tip of the iceberg.

Norris: Our opportunities are where they have always been—the ICU, long-term acute care (LTAC), and home care. The ICU is where ThermoFlo standard size devices have shown their ability. In the ICU, there are many things happening and with ThermoFlo providing therapeutic humidification, it is one less thing to be monitored. When patients are suctioned, it is simple to see whether the secretions are watery, moderate, or tenacious. Our history shows that secretions are overwhelmingly in the watery to moderate range.

The LTAC and skilled nursing facility markets are good for our Midi device. Patients here are generally less than 10 liter minute ventilation so the humidification capability of the Midi matches those patients. In home care, we provide trach HME devices with a Cough Relief Valve. In 21 years, we have never had a back order on any of our HME devices.

Alison Werner is associate editor for RT. For further information, contact [email protected].