ICU HospitalizationICU-tempNCT06942338
Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting.
An observational study of ICU Hospitalization and Surgical Intervention, run by Corsano Health B.V. at 1 site in Netherlands.
Trial summary
Fever is a common symptom in many health conditions, but current methods to monitor body temperature (BT) are either invasive, costly, or not continuous. The Corsano CardioWatch 287-2, a wristband that tracks multiple vital signs, offers a new way to monitor BT by measuring skin temperature and heat flux on the wrist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Hospitalization, Surgical Intervention
- What is being tested?
- Corsano CardioWatch 287-2
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We aim to include 120 individuals (mixed gender), of which 30-50% are displaying fever (>38°C), who are administered to the intensive care unit or the recovery room of the Reinier de Graaf Gasthuis.
Who may be able to join
- ≥ 18 years old;
- Able to provide consent
- Administered at the ICU or recovery room of the Reinier de Graaf hospita
Who cannot join
- Unable to wear the Corsano CardioWatch 287 or Radius-T sensor due to reasons such as allergic reactions, wounds, amputations etc.;
- Unable to receive rectal temperature monitoring;
- Thermoregulatory problems or diseases;
- Hyperthermia (>40°C);
- Known allergy to plastics / latex;
- Patient not willing to sign informed consent;
- Significant mental or cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Reinier de Graaf Gasthuis
Delft, South Holland, 2625AD
Eelko Ronner, MD, PhD, 015 - 260 33 20 ext. +31, eronner@rdgg.nl
Mariska van Vliet, MD, PhD
About this study
Official title: Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 2870-2 and Invasive Temperature Monitoring in an Intensive Care Setting.
Fever is a common symptom in many health conditions, but current methods to monitor body temperature (BT) are either invasive, costly, or not continuous. The Corsano CardioWatch 287-2, a wristband that tracks multiple vital signs, offers a new way to monitor BT by measuring skin temperature and heat flux on the wrist. It uses a machine learning algorithm to predict BT in real-time. The device has shown good results when compared to other non-invasive temperature measurements, like tympanic (ear) temperature, in stroke patients. However, it hasn't yet been compared to the gold standard of invasive rectal temperature monitoring in a clinical setting. This study aims to test the accuracy of the Corsano CardioWatch 287-2 in measuring body temperature against rectal temperature monitoring in a clinical environment.
Read the detailed description
Rationale Fever is one of the most common clinical symptoms. So far, clinically established methods to monitor body temperature (BT) are either invasive and expensive (blood, bladder or rectal catheter) and/or non-continuous (tympanic temperature measurements). A continuous and scalable BT monitoring solution is missing. The Corsano CardioWatch 287-2 is a wristband intended to monitor multiple vital signs, including BT. It does so by continuously measuring the wrist's skin temperature and corresponding heat flux, from which it predicts the BT. These BT predictions are performed in real-time by a machine learning algorithm on the wearable itself. The sensor system was shown to have good correlation with tympanic temperature measurements in an acute stroke clinical setting [1]. However, a clinical validation study in which the temperature sensor of the Corsano CardioWatch 287 is compared to invasive rectal temperature monitoring, is lacking.
Research objective This study's research objective is to investigate the validity of BT measurement through skin temperature and skin heat flux measurement by the Corsano CardioWatch 287-2 against invasive rectal temperature monitoring in a clinical setting.
Primary objective The main objective is to validate the clinical accuracy of BT spot measurements by the Corsano CardioWatch 287-2 according to ISO 80601-2-56;2017+A1;2018 [1,2].
Secondary objective The secondary objective is to compare continuous BT measurements by the Corsano CardioWatch 287-2 with measurements from a clinically conventional, continuous rectal temperature sensor. Bias and limits of agreement for CardioWatch 287-2 will also be calculated in comparison to the rectal temperature probe measurements.
As a third goal, simultaneously available thermometer readings of clinical thermometers, such as Radius-T temperature readings, tympanic temperature readings and rectal temperature probe readings, will be compared with each other to assess the difference in respect to each other.
The fourth goal of this study will be to record and evaluate adverse events from the wearable BT sensor (e.g., rash).
- Conditions
- ICU Hospitalization, Surgical Intervention
- Being tested
- Corsano CardioWatch 287-2
- Keywords
- wristband, wearable, body temperature, validation, rectal temperature, remote monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corsano CardioWatch 287-2Device
Temperature readings from wearable Cardiowatch BT sensor, wearable Radius-T BT sensor, tympanic temperature and rectal temperature will be collected. Each participant will remain in the study as long as the rectal temperature is measured with a maximum of 24 hours. Other than the wearable Cardiowatch, the Radius-T sensors, and the rectal thermometer no additional interventions will take place due to the study. Temperature monitoring of patients will be performed according to hospitals routine care and will not be affected by the study. Patients may receive additional treatment to ensure best care.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to the ICU or recovery room with and without fever | We aim to include 120 individuals (mixed gender), of which 30-50% are displaying fever (>38°C), who are administered to the intensive care unit or the recovery room of the Reinier de Graaf Gasthuis. Receives: Device: Corsano CardioWatch 287-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between four temperature readings
The primary objective of this study is to compare the body temperature readings of the BT sensor with temporally corresponding tympanic thermometer, Radius-T temperature sensor and rectal thermometer readings in 120 subjects. To comply with ISO 80601-2-56;A1:2018 [1,2], the data of the four thermometers will be simplified to one temperature data point per thermometer and participant, leading to a temperature quadruplet per participant. To ensure that each subject contributes an equal proportion or weight to the total number of samples, the samples will be stratified over subjects and temperature measurement ranges. This means that the samples for each subject in each range will be upsampled by randomly selecting samples with replacement until the maximum number of samples found over all ranges and all participants is reached.
The temperature quadruplet data points will be derived from simultaneous temperature readings taken by the four devices.
Measured: From enrollment up to 24 hours
Clinical repeatability calculation
In order to reduce potential bias by missing temperature measurements and variability in temperature readings within individual patients the clinical repeatability will be calculated complying with ISO 80601-2-56;A1:2018 [1,2]. First, the standard deviation ,j, of the quadruplet temperature measurements for each subject j will be calculated. Subsequently, the pooled standard deviation (clinical repeatability), r, for all subjects is calculated.
Measured: From enrollment up to 24 hours
Secondary outcomes (1)
Agreement between temperature reading of CardioWatch 287-2 and rectal temperature probe
The secondary objective of this study will be to compare the continuous temperature from the CardioWatch 287-2 measurement to available continuous clinical thermometer reading, collected by the rectal temperature probe. Additionally the bias and limits of agreement for the CardioWatch 287-2 in comparison to the rectal temperature probe measurements will be calculated. For this, three measures of quality will be determined: one is the mean absolute error (MAE) between the BT prediction of the CardioWatch 287-2 and the reference signal where the mean is taken over the whole measurement of a single candidate. The other two measures of quality are the bias and 2 standard deviations.
To investigate the third objective, the clinical bias and limits of agreement will be determined for clinical thermometer readings at the same point in time for the same participant (coming from tympanic thermometer and rectal temperature probe). This will be done according to the same method used for the pri
Measured: From enrollment up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corsano Health B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariska van Vliet, MD, PhD, Principal investigator, Reinier de Graaf Groep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942338
- Sponsor's protocol ID
- ICU-temp
- Acronym
- ICU-temp
- Status last verified
- Jun 2026
- First submitted
- 9 Apr 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 2870-2 and Invasive Temperature Monitoring in an Intensive Care Setting.
- ClinicalTrials.gov ID
- NCT06942338
- Acronym / sponsor ID
- ICU-temp / ICU-temp
- Conditions
- ICU Hospitalization, Surgical Intervention
- Keywords
- wristband, wearable, body temperature, validation, rectal temperature, remote monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Corsano Health B.V.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fever is a common symptom in many health conditions, but current methods to monitor body temperature (BT) are either invasive, costly, or not continuous. The Corsano CardioWatch 287-2, a wristband that tracks multiple vital signs, offers a new way to monitor BT by measuring skin temperature and heat flux on the wrist. It uses a machine learning algorithm to predict BT in real-time. The device has shown good results when compared to other non-invasive temperature measurements, like tympanic (ear) temperature, in stroke patients. However, it hasn't yet been compared to the gold standard of invasive rectal temperature monitoring in a clinical setting. This study aims to test the accuracy of the Corsano CardioWatch 287-2 in measuring body temperature against rectal temperature monitoring in a clinical environment.
Detailed description
Rationale Fever is one of the most common clinical symptoms. So far, clinically established methods to monitor body temperature (BT) are either invasive and expensive (blood, bladder or rectal catheter) and/or non-continuous (tympanic temperature measurements). A continuous and scalable BT monitoring solution is missing. The Corsano CardioWatch 287-2 is a wristband intended to monitor multiple vital signs, including BT. It does so by continuously measuring the wrist's skin temperature and corresponding heat flux, from which it predicts the BT. These BT predictions are performed in real-time by a machine learning algorithm on the wearable itself. The sensor system was shown to have good correlation with tympanic temperature measurements in an acute stroke clinical setting [1]. However, a clinical validation study in which the temperature sensor of the Corsano CardioWatch 287 is compared to invasive rectal temperature monitoring, is lacking.
Research objective This study's research objective is to investigate the validity of BT measurement through skin temperature and skin heat flux measurement by the Corsano CardioWatch 287-2 against invasive rectal temperature monitoring in a clinical setting.
Primary objective The main objective is to validate the clinical accuracy of BT spot measurements by the Corsano CardioWatch 287-2 according to ISO 80601-2-56;2017+A1;2018 [1,2].
Secondary objective The secondary objective is to compare continuous BT measurements by the Corsano CardioWatch 287-2 with measurements from a clinically conventional, continuous rectal temperature sensor. Bias and limits of agreement for CardioWatch 287-2 will also be calculated in comparison to the rectal temperature probe measurements.
As a third goal, simultaneously available thermometer readings of clinical thermometers, such as Radius-T temperature readings, tympanic temperature readings and rectal temperature probe readings, will be compared with each other to assess the difference in respect to each other.
The fourth goal of this study will be to record and evaluate adverse events from the wearable BT sensor (e.g., rash).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to the ICU or recovery room with and without fever | – | Device: Corsano CardioWatch 287-2We aim to include 120 individuals (mixed gender), of which 30-50% are displaying fever (>38°C), who are administered to the intensive care unit or the recovery room of the Reinier de Graaf Gasthuis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We aim to include 120 individuals (mixed gender), of which 30-50% are displaying fever (>38°C), who are administered to the intensive care unit or the recovery room of the Reinier de Graaf Gasthuis.
Key inclusion criteria (3 listed)
- ≥ 18 years old;
- Able to provide consent
- Administered at the ICU or recovery room of the Reinier de Graaf hospita
Key exclusion criteria (7 listed)
- Unable to wear the Corsano CardioWatch 287 or Radius-T sensor due to reasons such as allergic reactions, wounds, amputations etc.;
- Unable to receive rectal temperature monitoring;
- Thermoregulatory problems or diseases;
- Hyperthermia (>40°C);
- Known allergy to plastics / latex;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corsano CardioWatch 287-2Temperature readings from wearable Cardiowatch BT sensor, wearable Radius-T BT sensor, tympanic temperature and rectal temperature will be collected. Each participant will remain in the study as long as the rectal temperature is measured with a maximum of 24 hours. Other than the wearable Cardiowatch, the Radius-T sensors, and the rectal thermometer no additional interventions will take place due to the study. Temperature monitoring of patients will be performed according to hospitals routine care and will not be affected by the study. Patients may receive additional treatment to ensure best care. | Device | Patients admitted to the ICU or recovery room with and without fever |
Primary outcome
Agreement between four temperature readings
Time frame: From enrollment up to 24 hours
The primary objective of this study is to compare the body temperature readings of the BT sensor with temporally corresponding tympanic thermometer, Radius-T temperature sensor and rectal thermometer readings in 120 subjects. To comply with ISO 80601-2-56;A1:2018 [1,2], the data of the four thermometers will be simplified to one temperature data point per thermometer and participant, leading to a temperature quadruplet per participant. To ensure that each subject contributes an equal proportion or weight to the total number of samples, the samples will be stratified over subjects and temperature measurement ranges. This means that the samples for each subject in each range will be upsampled by randomly selecting samples with replacement until the maximum number of samples found over all ranges and all participants is reached. The temperature quadruplet data points will be derived from simultaneous temperature readings taken by the four devices.
Clinical repeatability calculation
Time frame: From enrollment up to 24 hours
In order to reduce potential bias by missing temperature measurements and variability in temperature readings within individual patients the clinical repeatability will be calculated complying with ISO 80601-2-56;A1:2018 [1,2]. First, the standard deviation ,j, of the quadruplet temperature measurements for each subject j will be calculated. Subsequently, the pooled standard deviation (clinical repeatability), r, for all subjects is calculated.
1 secondary outcome
Agreement between temperature reading of CardioWatch 287-2 and rectal temperature probe
Time frame: From enrollment up to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariska van Vliet, MD, PhD principal investigator
Reinier de Graaf Groep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Hospitalization and Surgical Intervention, run by Corsano Health B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eelko Ronner, MD, PhD (015-2603320 ext. +31, eronner@rdgg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between four temperature readings (time frame: From enrollment up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.