RecruitingOBSERVATIONAL

Respiration From Pleth Validation

This study aims to make measuring breathing rates easier and more accurate. Currently, counting breaths by hand can be tricky and lead to mistakes. We're testing a new device from Philips that can figure out your breathing rate using a sensor often placed on your finger, much like the one that measures oxygen levels. We'll compare this new method with a more traditional way of measuring breathing, called capnography, which will serve as our gold standard. The study involves both children and adults who are already in the hospital. You'll wear the sensors during a single visit, and we'll check how well the new device performs. No medical decisions will be based on these study measurements.

At a glance

Status

Recruiting

Sponsor

Philips Clinical & Medical Affairs Global

Enrolment target

113

Start

06 Feb 2026

Estimated completion

25 May 2026

Respiratory Rate Monitoring

What is this study about?

When you're in the hospital, nurses and doctors regularly check your vital signs, like your heart rate, temperature, and breathing rate. Your breathing rate is really important because changes in how quickly you breathe can be an early sign that you might be getting unwell. However, counting breaths by hand can be difficult and sometimes not very accurate.

This study is looking at a new technology developed by Philips that aims to make measuring your breathing rate much more reliable. This new method uses a special sensor, similar to the one used to check your oxygen levels (often placed on your finger, nose, or ear). It can measure your breathing by looking at the tiny changes in blood flow under your skin. We want to find out how accurate this new way of measuring breathing is compared to the current methods.

To do this, we'll ask volunteers – both adults and children who are already staying in the hospital – to wear this new sensor at the same time as a standard breathing monitor (called capnography). The capnography monitor will give us the 'gold standard' measurement to compare the new sensor against. We'll be checking things like how close the new sensor's readings are to the standard monitor, and how quickly it can give a reliable reading. This is all about making hospital care safer and more efficient by improving how we monitor patients' breathing.

Key takeaways

Tests a new finger/nose/ear sensor to measure breathing rate.
Compares the new sensor to a standard breathing monitor.
Aims to make breathing rate monitoring more accurate.
Involves one short visit for volunteers already in hospital.
No impact on your current medical care.
Open to both adults and children (aged 4+).

Who may be eligible?

This study is looking for adults who are 18 years or older, and children aged between 4 and 17 years old. For children, a parent or guardian will also need to give their permission. You should be able to understand and agree to take part in the study.

Your weight needs to be suitable for at least one of the special sensors we'll be using. For example, if you're an adult, you generally need to weigh more than 50 kg (around 7 stone 12 pounds). If you're a child, your weight will determine which sensor is best for you. You also need to be able to wear the study devices comfortably for the whole visit and be having regular spot-check vital signs measurements as part of your usual hospital care.

There are also some reasons why you might not be able to join. For example, if you are receiving end-of-life care, have tremors (shaking), a heart pacemaker, or a heart condition called atrial fibrillation. We also can't include people who need extra oxygen at the time of the study, are very unwell (critically ill), are pregnant or breastfeeding, or have skin conditions, injuries, or piercings on the fingers, nose, or ear where the sensors would be placed. You also can't have nail polish or artificial nails if the finger sensor is used.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 or older, or between 4 and 17 with parent permission?
Do you weigh enough for the sensors (e.g., adult over 50kg)?
Are you able to wear sensors on your finger, nose, or ear without pain or existing skin issues?
Are you NOT currently receiving extra oxygen?
Do you NOT have a heart pacemaker, tremors, or atrial fibrillation?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have just one study visit. During this visit, we will gently place two different types of sensors on you. One will be the new breathing sensor, which will be placed on your finger, nose, or ear, depending on what's best for you and your age/weight. At the same time, we'll also use a small capnography sensor, which is a standard way to measure breathing and involves a small tube near your nose or mouth.

You'll wear these sensors at the same time for about 20 minutes while you are breathing normally. For a short part of this time (about 5 minutes), we'll also manually count your breaths. The information collected from the sensors will be recorded for analysis. You won't be given any new medications as part of this study, and the collected information won't be used to make decisions about your direct care in the hospital during the study.

Potential risks and benefits

Taking part in this study could help improve how patients' breathing is monitored in the future, potentially leading to earlier detection of problems. There are very few risks expected, as the sensors are designed for medical use and are placed on the skin. You might find wearing the sensors a little uncomfortable or feel some mild irritation where they are attached. Remember, you can choose to withdraw from the study at any time without giving a reason, and this will not affect your care in the hospital.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Duke University Hospital
Verified postcode
Durham, United States· Recruiting
Ysbyty Gwynedd
Verified postcode
Bangor, United Kingdom· Not yet recruiting

Common questions

What is 'Respiration from Pleth'?

It's a new way to measure your breathing rate using a sensor, often on your finger, that also checks your oxygen levels. It looks at tiny changes in your body to work out how fast you're breathing.

Will this study affect my medical treatment?

No, the measurements taken during this study are purely for research. They won't be used to make any decisions about your hospital care on the day you take part.

Is the study suitable for children?

Yes, children aged 4 and older can take part, with permission from their parent or guardian.

How long will I need to be in the study?

You'll only need to attend for one study visit, which will involve wearing the sensors for about 20 minutes.

What if I get uncomfortable during the study?

You can ask for the sensors to be removed and withdraw from the study at any time, for any reason, without affecting your care.

How to find out more

Nero Evero, Clinical Study Manager, MS

nero.evero@philips.com +1 720-201-7689 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.