Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis

Sponsor
Check Point R & D Ltd
Study ID
NCT07595848
Status
Not Yet Recruiting

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Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • CPC12S Telemonitoring System with Temperature/Humidity Sensor — DEVICE
    The CPC12S telemonitoring system will be used together with the CPC temperature and humidity sensor to collect physiological parameters, body temperature, and humidity data from ICU patients during the monitoring period.
  • IDRO Sweat Lactate Sensor — DEVICE
    The investigational IDRO sweat lactate sensor will be used to collect sweat lactate measurements. The sensor will be integrated with the CPC system for data transmission, visualization, and analysis.

Study Details

The purpose of this clinical investigation is to evaluate the integration of data from the CPC12S telemonitoring device, the CPC temperature/humidity sensor, and the IDRO sweat lactate sensor into a single system for the prediction of sepsis onset in ICU patients at risk of developing sepsis. Patients will be monitored for up to 48 hours, and the collected physiological and biomarker data will be used to support the development of artificial intelligence and machine learning models for sepsis prediction.

Key Dates

First listed
May 19, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CPC12S + Temperature/Humidity Sensor
    Participants will be monitored using the CPC12S telemonitoring device together with the CPC temperature and humidity sensor. Data will include physiological parameters, body temperature, and humidity during ICU monitoring.
  • Experimental: CPC12S + Temp/Humidity + IDRO Sensor
    Participants will be monitored using the CPC12S telemonitoring system together with the CPC temperature and humidity sensor and the investigational IDRO sweat lactate sensor. Data will include physiological parameters, temperature, humidity, and sweat lactate measurements.

Primary Outcome Measure

Area under the receiver operating characteristic curve (AUC-ROC) of the integrated sensor-based model for prediction of sepsis onset [ Time Frame: Up to 48 hours of patient monitoring ]

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