Evaluating Wearable Smart Sensors for Continuous Measurement of Vital Signs in ICU Patients and Healthy Children Under 18

What this Trial Is About

Researchers are evaluating biocompatible wireless electronic devices designed to continuously and non-invasively measure vital signs and physiological data in patients within the Intensive Care Unit (ICU) and in non-ICU pediatric populations. This observational study aims to compare data from these novel wearable sensors with standard monitoring devices to improve patient care in critical settings, particularly focusing on children under 18 years of age. The study is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago and includes patients from multiple ICUs and healthy volunteers who visit a pediatric autonomic medicine center. The study involves placing up to five wireless wearable vital sign monitors on ICU patients for up to 48 hours, attached to various body locations such as the chest, back, or limbs using medical-grade adhesives or hypoallergenic soft wrap-around devices. For non-ICU participants, these sensors are worn for up to three hours during a single outpatient visit. The devices continuously capture data including blood pressure, respiratory rate using bioimpedance, and skin temperature, while standard cuff-based blood pressure and skin temperature measurements are also recorded for comparison. Optional video monitoring of participant movement and position may be conducted with family consent. Participants undergo screening through medical record reviews or parent/guardian interviews depending on ICU or non-ICU status. Skin integrity is closely monitored before, during, and after sensor use using validated scales and photographs. Data from wearable sensors and standard monitoring systems are securely collected and stored for analysis. After the monitoring period, parents complete brief questionnaires about the devices. The primary outcome measures focus on continuous non-invasive blood pressure monitoring for up to 48 hours, with secondary outcomes assessing the accuracy of other physiological signals.

Evaluating Wearable Smart Sensors for Continuous Measurement of Vital Signs in ICU Patients