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

NCT06942338 | Not Yet Recruiting

• 1 other identifier: ICU-temp
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ICU Hospitalization; Surgical Intervention

Keywords

wristband; wearable; body temperature; validation; rectal temperature; remote monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Agreement between temperature reading of CardioWatch 287-2 and rectal temperature probe

  From enrollment up to 24 hours

Study Arms (1)

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

Interventions

Corsano CardioWatch 287-2 DEVICE

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.

Patients admitted to the ICU or recovery room with and without fever

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corsano Health B.V.: lead

Study Sites (1)

Reinier de Graaf Gasthuis

Delft, South Holland, 2625AD, Netherlands

Location

Study Officials

• Mariska van Vliet, MD, PhD

  Reinier de Graaf Groep

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eelko Ronner, MD, PhD

CONTACT

015-2603320; eronner@rdgg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)