Remotely Conducting Respiratory Clinical Research

Conducting research in the respiratory space has always been intricate. Lungs vary across demographics, baseline standards are fractured and often incomplete, and spirometry is a difficult procedure to get subjects to perform correctly.

This has resulted in many trials and studies being limited by the geography of the research center and bandwidth of the clinical team. Most studies require a patient to visit the clinic multiple times over the length of the study to perform spirometry under the coaching of a respiratory therapist.

This system, while inefficient, has basically worked well from 1960 [1] until March of 2020. When faced with the outbreak of COVID-19 many respiratory clinics shut their doors for all nonessential visits.

In-Clinic Spirometry is Now Risky

Even now as restrictions are loosening in some areas, in-clinic spirometry is still considered a high-risk procedure by the American Thoracic Society. This is because the forced exhale procedure can cause a large volume of aerosolized particles from the respiratory system to evacuate the body. This process puts everyone in the immediate vicinity at a much higher risk of contracting the disease from an infected patient.

This embargo on spirometry and in-clinic visits resulted in an “on pause until further notice” for most respiratory trials around the world.

The likelihood of COVID-19 being a short-term problem is very slim. It makes sense to develop a longterm strategy for coping with the new guidelines.

Remote Spirometry Provides a Way Forward

At VitalFlo, we have built our platform for researchers and clinicians to remotely monitor their patients’ respiratory condition. To do this we use spirometry and symptom surveys collected through a smartphone app; and air quality measurements from the EPA as well as an indoor air quality monitoring device.

I wish I could say our product offering was a brilliant strategic maneuver to capture the market as soon as the need arose, but the truth is far less interesting: the idea that would become VitalFlo was first posed by Dr. David Peden, the now-former president of the AAAAI, back in 2013. His initial concept was to prevent emergency room visits by collecting hard and soft endpoints from patients daily as opposed to the current quarterly visits.

So, a team of dedicated University of North Carolina at Chapel Hill and North Carolina State University researchers set to work.

From the outset, VitalFlo has had one guiding principle: clinical validation.

After three years of rigorous incubation at the UNC/NCSU joint department of biomedical engineering in partnership with the UNC School of Medicine, VitalFlo launched as a company in 2017. We have continued to focus first on clinical validation; however, now as a digital health company we had additional directives:

1. Clinical Validation
2. Accuracy of Data
3. Patient Privacy
4. Return on Investment for Customers

Clinical Validation

At VitalFlo we have completed two clinical studies. We are in the process of wrapping up our third. Our first funding was from the National Science Foundation (NSF) from whom we now received an SBIR Phase I and II.

Our home base is the clinical research lab of Dr. Michelle Hernandez at UNC School of Medicine, where we will continue to develop and conduct respiratory research. Since launching as a company, we have gone on to partner with many of the academic research centers across the country.

Clinical validation is not a checkbox for us. Through our existing and future partnerships, we are continually working to iterate and improve the capabilities of our platform within the proper scientific framework

Accuracy of Data

We spend the majority of our time in the VitalFlo product team focused on how we consistently collect accurate data from patients at a high adherence rate. The bottom line is that if we do not collect accurate data, none of the data we collect matters.

Furthermore, we have a difficult physiological measurement to capture. Spirometry is traditionally a coached procedure that requires multiple attempts. We approached this problem with our mental model validation. Our first two clinical studies at the UNC school of medicine were studying the ability to capture accurate spirometry with a handheld spirometer.

We have spent more time and money on this problem than any other. The solution we have come to is video coaching of the correct technique, interactive user experience which the patient ‘drives’ to ensure proper completion of the procedure, and rigorous data validation on our backend.

The result is a smartphone app with a simple and efficient interface and a daily adherence rate of 60% as of May 2020.

Patient Privacy

At VitalFlo patient privacy is at the forefront of our minds. Digital health products can only consciously collect patient data if they can protect and be good stewards of that data.

An in-depth look at our security policies and standards is available upon request, but to answer the initial questions, we are HIPAA compliant, and we have been approved by three IRBs and their security reviews (and counting).

Return on Investment

At VitalFlo we are only as successful as our partners. There will always be humans to answer your questions. We will always begin an engagement by determining first what you need to achieve and if there is alignment.

And I myself will always be available for product feedback and feature suggestions. In every case I have seen so far an improvement for one customer makes the lives of all customers better.

If you are interested in learning more about our platform or what we can do to help your study or clinical practice reach out at any time: ryan@vitalflohealth.com

All materials on Clinical validation, Data Accuracy, and Patient privacy are available upon request.

[1] https://www.jonesmedical.com/brief-history-spirometer/