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

ConditionPrematurity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorAnn & Robert H Lurie Children's Hospital of Chicago

About this trial

The purpose of this study is to develop biocompatible wireless electronic devices that will allow continuous, non-invasive hemodynamic and physiology measurements in the ICU.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Admitted to one of the four ICUs at Lurie Children's or Prentice Women's Hospital

Under 18 years of age

Under 18 years of age

Willing to visit the Center for Autonomic Medicine in Pediatrics (CAMP) for a one time study visit

Disqualifiers

A skin abnormality that would potentially increase the risk of device

18 years of age or older

Determined by an attending physician or bedside care team to be too unstable (patient) or experiencing too much stress (family)

A skin abnormality that would potentially increase risk of device use

Trial population

Patients admitted to one of 3 ICUs at Lurie Children's, or healthy volunteers visiting CAMP at Lurie Children's

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Wireless Wearable Vital Sign Monitor

    Device

    Placement of wireless wearable vital sign monitors on patients limbs for up to 48 hours

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: ICU Population1 intervention
Group B: Non-ICU Population1 intervention

Trial outcomes

Primary outcomes

1

Continuous non-invasive BP monitoring

Recorded measurements of BP as compared to the ICU standard of care monitoring, including both arterial line measurements and cuff-based measurements of the arm (mm Hg).

Time frame
up to 48 hours

Secondary outcomes

1

Accuracy of Other Physiologic Signals

correlation of vital signs to current technology used on the units: heart rate (beats/min); respiratory rate (breaths/min); temperature (degrees Celsius); oxygen saturation (SpO2, %)

Time frame
up to 48 hours

Other outcomes

Sponsors and contacts

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