PneumoRator Study
Research type
Research Study
Full title
Clinical validation of the PneumoRator respiratory rate sensor in a perioperative cohort
IRAS ID
336516
Contact name
Alexander Jackson
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Healthcare workers measure heart rate, blood pressure, temperature, oxygen levels and breathing rate to monitor how unwell a patient is. All these apart from breathing rate are now normally measured by machines. But there still isn’t a machine that does this well enough for breathing rate to be used in most places. The machines we do have are either uncomfortable or don’t work well on patients who are moving. Instead, a healthcare worker will count the number of breaths a patient takes. This needs staff time and isn’t very accurate.
We know changes in breathing rate can happen any time. But we normally only measure it every few hours because it takes time. If we could monitor breathing rate all the time, we might pick up people getting sick earlier and be able to treat them more quickly, which could save lives.
A team at the University of Southampton has made a small device, called a PneumoRator, that gets stuck to onto a person’s chest. Once stuck there it can measure their breathing rate and store or send that information wirelessly. The device has been tested on healthy volunteers but has never been tested on patients in hospital.
In this study the team will put the device on patients having major operations. All these patients will already be taking part in another study called CIPHER-HPI. That study already records lots of information about patients, including their breathing rate using the best measurement we have, where a patient’s breathing is measured by a gas they breathe out. The gas is carbon dioxide, and the measurement is called capnography. This way of measuring is only used in operating theatres and intensive care units but is a good way to check if the PneumoRator is accurate.
We want to attach the PneumoRator to patients chests before they go to sleep for their operation and leave it there for the first few days after their operation. This will let us see how the PneumoRator compares to capnography and manual breath counting. It will also let us see how the device works at different times in the patient’s journey. We will look at the time when they are asleep, when breathing is controlled by a machine. Then when they wake up we can measure with both capnography and the PneumoRator. Finally, when they go to the high dependency ward, we will compare it against manual counting. We will also ask patients how they found wearing the device and any problems they found.
With this information we hope to show the PenumoRator is accurate at measuring breathing rate and comfortable for patients. This will help us get the device approved for use in hospitals and other places where breathing rate needs to be measured accurately.
REC name
South East Scotland REC 02
REC reference
24/SS/0036
Date of REC Opinion
10 Jul 2024
REC opinion
Further Information Favourable Opinion