Title
Comparative evaluation of core temperature measurement and invasive temperature monitoring in an intensive care setting ICU-TEMP

Rationale
Fever is one of the most common clinical symptoms. So far, clinically established methods to monitor core body temperature (CBT) are either invasive and expensive (blood, bladder or rectal catheter) and/or non-continuous (tympanic temperature measurements). A continuous and scalable CBT monitoring solution is missing. The Corsano CardioWatch 287-2 is a wristband intended to monitor multiple vital signs, including CBT. It does so by continuously measuring the wrist’s skin temperature and corresponding heat flux, from which it predicts the CBT. These CBT predictions are performed in real-time by a machine learning algorithm on the wearable itself.

Primary End-Point
The main objective is to validate the clinical accuracy of CBT spot measurements by the Corsano CardioWatch 287-2 according to ISO 80601-2-56;2017+A1;2018.

Secondary End-Point
The secondary end-point is to compare continuous CBT measurements by the Corsano CardioWatch 287-2 with measurements from a clinically conventional, continuous rectal temperature sensor.

Study Design
This is a single-center study. Temperature readings from wearable CBT sensors, tympanic temperature and rectal temperature will be collected. Each participant will remain in the study for a minimum of 3 hours and up to 6 days. Other than the wearable CBT sensor, 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.

Study population
We aim to include 105 individuals (mixed gender), of which 30-50% are displaying fever (>38°C), who are administered to the intensive care unit of the Reinier de Graaf Gasthuis.

Inclusion / Exclusion criteria
Inclusion Patients:
● ≥ 18 years old;
● able to provide consent.
● receiving rectal temperature monitoring as standard of care in the ICU of the Reinier de Graaf hospital.

Exclusion:
● Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
● Unable to receive rectal temperature monitoring;
● Active external heating or active external cooling of the patient (targeted temperature management system);
● Thermoregulatory problems or diseases;
● Sepsis / cold fever;
● Hyperthermia;
● Known allergy to plastics / latex;
● Pregnant women;
● Breastfeeding women;
● Unable or not willing to sign informed consent;
● Significant mental or cognitive impairment.

Study center
Reinier de Graaf Gasthuis Delft (NL)

Start time, Duration
July 2024, 3 months