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

NCT06942338 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-04-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Corsano Health B.V.

    lead INDUSTRY

Principal Investigators

  • Mariska van Vliet, MD, PhD · Reinier de Graaf Groep

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06942338 on ClinicalTrials.gov