Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting. (ICU-temp)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Intervention; ICU Hospitalization
• Intervention / Treatment: Device: Corsano CardioWatch 287-2

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Eelko Ronner, MD, PhD; Phone Number: +31 015-2603320; Email: eronner@rdgg.nl

Study Locations

• Netherlands
  • South Holland
    • Delft, South Holland, Netherlands, 2625AD
      • Reinier de Graaf Gasthuis
      • Contact: Eelko Ronner, MD, PhD; Phone Number: +31 015 - 260 33 20; Email: eronner@rdgg.nl
      • Principal Investigator: Mariska van Vliet, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• ≥ 18 years old;
• Able to provide consent
• Administered at the ICU or recovery room of the Reinier de Graaf hospita

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Corsano CardioWatch 287-2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment up to 24 hours

Collaborators and Investigators

• Sponsor: Corsano Health B.V.
• Investigators: Principal Investigator: Mariska van Vliet, MD, PhD, Reinier de Graaf Groep

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: wearable; body temperature; validation; remote monitoring; rectal temperature; wristband
• Other Study ID Numbers: ICU-temp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No