This study*s research objective is to investigate the validity of BT measurement through skin temperature and skin heat flux measurement by the Corsano CardioWatch 287-2 against invasive rectal body temperature monitoring devices in a clinical…
ID
Source
Brief title
Condition
- Body temperature conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
The secondary objective is to compare continuous CBT measurements by the
Corsano CardioWatch 287-2 with measurements from a clinically conventional,
continuous rectal temperature sensor. Additionally, bias and limits of
agreement for CardioWatch 287-2 will be calculated in comparison to the rectal
temperature probe measurements.
As a third goal, simultaneously available thermometer readings of clinical
thermometers, for example tympanic temperature readings, Radius-T temperature
sensor readings and rectal temperature probe readings, 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 CBT sensor (e.g., rash).
Background summary
Fever is one of the most common clinical symptoms. So far, clinically
established methods to monitor body temperature (BT) are either invasive and
expensive (blood, bladder or rectal catheter) and/or non-continuous (tympanic
temperature measurements). A continuous and scalable BT monitoring solution is
missing. The Corsano CardioWatch 287-2 is a wristband intended to monitor
multiple vital signs, including BT. It does so by continuously measuring the
wrist*s skin temperature and corresponding heat flux, from which it predicts
the BT. These BT predictions are performed in real-time by a machine learning
algorithm on the wearable itself. The sensor system was shown to have good
correlation with tympanic temperature measurements in an acute stroke clinical
setting. However, a clinicial validation study in which the sensor is
integrated in the Corsano CardioWatch 287-2 is lacking.
Study objective
This study*s research objective is to investigate the validity of BT
measurement through skin temperature and skin heat flux measurement by the
Corsano CardioWatch 287-2 against invasive rectal body temperature monitoring
devices in a clinical setting.
Study design
This is a single-center validation study in the Renier de Graaf Gasthuis.
Temperature readings from wearable BT sensors, tympanic temperature, Radius-T
temperature sensor and rectal temperature will be collected. Study participants
will be monitored with a maximum of 24 hours. Other than the wearable BT
sensor, the Radius-T temperature sensor 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.
Study burden and risks
The study involves wearing the Corsano CardioWatch 287-2 during the stay in the
Intensive Care Unit or recovery room. This does not entail significant risk for
the patient. Wearing several sensors for a time might be slightly
uncomfortable. Skin irritation may occur. Placement of the rectal probe can
cause discomfort, irritation or rectal abrasion. However, the burden and time
effort for included participants is judged as low. Participation is voluntary.
Relevant incidental findings are not expected. In the future, the patient
population involved in this trial will benefit from a continuous monitoring
device that is considerably less intrusive than conventional monitoring
devices. This will facilitate long-term continuous intra- and extramural
monitoring of vital signs.
Wilhelmina van Pruisenweg 35
Den Haag 2595 AN
NL
Wilhelmina van Pruisenweg 35
Den Haag 2595 AN
NL
Listed location countries
Age
Inclusion criteria
Patients
- >= 18 years old;
- Able to provide consent
- Administered at the ICU or recovery room of the Reinier de Graaf hospital.
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;
- Thermoregulatory problems or diseases;
- Hyperthermia;
- Known allergy to plastics / latex;
- Patient not willing to sign informed consent;
- Significant mental or cognitive impairment.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL86414.058.24 |