51³Ô¹ÏÍø

Study parameters and regulatory requirements for respiratory rate monitor clinical validation testing can be difficult to interpret. For more than three decades, our consultative experts have helped innovators successfully navigate complex regulatory requirements and will support and guide you from protocol development to the development of regulatory ready reports.

We provide both routine and custom respiratory rate monitoring test programs that can be utilized for focused development tests and FDA and other regulatory agency submissions. When you partner with Element, the process is simplified. We offer turnkey solutions, from drafting protocols to guiding you in setting up a successful study for regulatory submission.

Respiratory rate is one of the vital signs used to monitor overall health in critical conditions and can indicate respiratory distress or respiratory depression. While normal resting respiratory rate is around 12-16 breaths per minute, lower respiratory rates may indicate a crisis in the case of diseases such as asthma and COPD. Respiratory are routinely used in healthcare settings, from health physicals to surgery and critical care, to track the well-being of patients. Respiratory rate monitoring sensors are also routinely integrated into wearable technology, such as smart watches and smart devices.

Respiratory rate monitor clinical validation testing overview

Regulatory agencies require that accuracy of respiratory rate devices be tested in humans, and in some cases, patients with medical conditions. Simulators may not be used to evaluate accuracy in respiratory rate monitoring devices.

Your entire respiratory rate accuracy validation study will be conducted by Element. Our experienced team will take care of protocol design, IRB submission and management, recruitment and payment of participants, study performance, analysis of data, and assembling high-quality data packages ready for regulatory submission. Want to know more? Get in touch with our team today.

How respiratory rate accuracy validation testing is conducted

Respiratory rate accuracy performance of the test monitor is evaluated in highly controlled conditions over a range of respiratory rates in specific demographics. Our participant database reflects various comorbidities including COPD and asthma as well as healthy individuals. Participants include a range of pigmentation, body mass, and age, including infants.

A range of respiratory rates (typically around 5-50 breaths per minute) will be elicited from each healthy volunteer test subject. The respiratory rate will be measured simultaneously with an EtCO₂ reference device and the sponsor device being tested. Participants will be selected from both healthy populations and populations with various comorbidities.

Data is collected at a frequency of 100Hz. Scored waveforms and raw data are provided upon request in addition to other engineering data as part of the development process or as part of the final report.

The 51³Ô¹ÏÍøadvantage

Drawing on our substantial expertise in the physiological monitoring space, in addition to a network associate hospitals and fully equipped labs, we continually deliver best-in-class, complete solutions. Element’s regulatory experts will serve as an extension of your team, guiding and advising you throughout the regulatory process, including discussions with the regulatory bodies.

To learn more about respiratory rate monitor clinical validation and our clinical validation wrap-around services, including human factors testing, contact us today.