Performance Study of the Thermodiag Solution for Body Temperature Measurement
Doctors are testing a new device called Thermodiag to measure body temperature more easily and safely, especially for patients in intensive care. Currently, measuring temperature accurately often involves methods that can have risks like infection or bleeding. This study wants to see how well the Thermodiag device works compared to these standard methods. The main goal is to find a way to continuously check a patient's temperature from outside the body, making it more comfortable and reducing potential health problems. It's hoped this new device could offer a better way to monitor very ill patients.
At a glance
What is this study about?
This study is looking at a new way to measure a person's body temperature. When someone is very unwell, particularly in hospital intensive care units, doctors need to know their exact body temperature to give them the best care. Currently, methods to get a very accurate temperature can involve putting devices inside the body, which, while effective, can sometimes lead to issues like infections or small bleeds.
The Thermodiag device is being developed as a potential new method that wouldn't need to go inside the body. This study is designed to see if it works as well as the standard methods we use now. The researchers want to make sure it's accurate and reliable.
Ultimately, if successful, this new technology could make temperature monitoring safer and more comfortable for patients, reducing the risks associated with current methods and making it easier for healthcare professionals to keep a close eye on their patients' health.
Key takeaways
- The study tests a new non-invasive body temperature device.
- It aims for safer, more comfortable temperature monitoring for sick patients.
- It compares the new Thermodiag device with current methods.
- Participation involves wearing a device on your arm during critical care.
- You can stop participating at any time without affecting your care.
Who may be eligible?
To join this study, you would need to be an adult between 18 and 80 years old. You must be in an intensive care unit (often called 'critical care' in the UK) because you have a serious illness that could affect your vital signs or body functions and might need special support.
There are also some reasons why you might not be able to join. For example, if you have very large arms (over 47 centimetres around) or if you have burns, very sensitive skin, or tattoos on your arm where the device would be worn. You also can't take part if you have certain medical devices like a pacemaker, are on dialysis, or undergoing specific medical scans (like an MRI or a heart-lung bypass procedure).
Additionally, if you are pregnant or breastfeeding, have a silicone allergy, or are already involved in another medical study, you wouldn't be able to participate in this one. You, or a trusted family member, would also need to understand the study and agree to take part.
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 between 18 and 80 years old?
- Are you currently in an intensive care unit?
- Do you have any skin conditions or tattoos on your arm where a device would sit?
- Do you have a pacemaker or other active implanted medical device?
- Are you pregnant or breastfeeding?
- Would you (or a family member) be able to provide informed consent?
What does participation involve?
If you are eligible and agree to take part, the Thermodiag device would be placed on your arm to continuously measure your core body temperature. This will be compared with temperature readings taken using the standard methods already in use in the hospital. You wouldn't need to take any new medication specifically for the study. The study would last as long as you are in the critical care unit and need your temperature monitored. There are no additional hospital visits or follow-ups required specifically for the study once you leave critical care.
Potential risks and benefits
Locations (4)
- Centre Hospitalier De FleyriatVerified postcodeBourg-en-Bresse, France
- Centre Hospitalier Intercommunal - Nord-ArdennesVerified postcodeCharleville-Mézières, France
- Hôpital Privé de l'Ouest ParisienVerified postcodeTrappes, France
- Hôpital Nord Franche-ComtéVerified postcodeTrévenans, France
Common questions
What is 'core temperature'?
Core temperature is the temperature of your internal organs and deep tissues, which is usually very stable. It's a key indicator of your health.
How does the Thermodiag device work?
While the exact details aren't fully public, it's a device placed on the outside of your arm that uses technology to estimate your core body temperature without needing to go inside your body.
Will this device replace my current temperature checks?
No, during the study, your existing temperature checks will continue as normal. The Thermodiag device will be used in addition to these, so doctors can compare its readings.
Is the Thermodiag device safe?
The study aims to check its safety and effectiveness. It's designed to be non-invasive, meaning it doesn't go inside your body, which generally lowers risks.
Will taking part affect my regular medical treatment?
No, participating in this study will not change or interfere with the standard medical care and treatments you receive from your doctors.
How to find out more
Benjamin MENARD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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