ICU-TEMP Study

Comparative evaluation of body temperature measurement and invasive temperature monitoring in a hospital care setting - ICU-TEMP Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57407

Enrollment

Registered

2024-05-06

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever pyrexia Fever

Interventions

The Corsano CardioWatch 287-2 will be investigated in this study. The CardioWatch 287-2 is a remote monitoring device intended for continuous and spot measurements collection of physiological data in

whereas only pulse rate, Sp02, respiration rate, skin temperature &amp

activity are FDA cleared. The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years ol

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients - >= 18 years old; - Able to provide consent - Administered at the ICU, recovery room or cardiology unit of the Reinier de Graaf hospital or of the CENA Research Institute Houston.

Exclusion criteria

Exclusion criteria: - Unable to wear the Corsano CardioWatch 287 or Radius-T temperature sensor due  to reasons such as allergic reactions, wounds, amputations etc.; - Unable to receive rectal temperature monitoring  - Unable to receive internal temperature monitoring by ingestible due to impaired gastro-intestinal tract;- Thermoregulatory problems or diseases; - Hyperthermia; - Known allergy to plastics / latex; - Patient not willing to sign informed consent; - Significant mental or cognitive impairment.

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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, as well as an ingestible temperature sensor Bias and limits of agreement for CardioWatch 287-2 will also be calculated in comparison to the reference measurements.As a third goal, simultaneously available thermometer readings of clinical thermometers, such as Radius-T temperature readings, tympanic temperature readings and temperature readings by an ingestible capsule (BodyCAP), 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).	—

Measure

Time frame

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, as well as an ingestible temperature sensor Bias and limits of agreement for CardioWatch 287-2 will also be calculated in comparison to the reference measurements.As a third goal, simultaneously available thermometer readings of clinical thermometers, such as Radius-T temperature readings, tympanic temperature readings and temperature readings by an ingestible capsule (BodyCAP), 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).

—

Countries

Netherlands, United States

Contacts

Public ContactN Jaspers

Corsano Health B.V.

elena@corsano.com+31 638478134

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026