Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting.
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCorsano Health B.V.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old;
Able to provide consent
Administered at the ICU or recovery room of the Reinier de Graaf hospita
Disqualifiers
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);
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Corsano CardioWatch 287-2
DeviceTemperature 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Patients admitted to the ICU or recovery room with and without fever1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment up to 24 hours2
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.
Time frame
From enrollment up to 24 hoursSecondary 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
Time frame
From enrollment up to 24 hoursSponsors and contacts
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Source ClinicalTrials.gov
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