Validation of Continuous Monitoring of Vital Signs in Children With a Connected Patch
ConditionVital Signs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-18
SponsorSt. Justine's Hospital
About this trial
Small connected devices monitoring vital signs do not exist in children although they could be very useful to monitor patients once they have left the pediatric intensive care unit (PICU) in order to early identify patients at risk of PICU readmission.
The main objective of this study is to assess the accuracy of a connected thoracic patch (VT-Patch) for the continuous monitoring of vital signs in PICU patients.
This monitoring device will be used to monitor children in PICU for 8 hours and results will be compared to the standard of care in the unit which is the Philips monitoring system.
The investigators will assess the device's accuracy for the monitoring of 4 vital signs (SpO2, heart rate, respiratory rate and temperature) and perform exploratory assessment of three additional parameters (EKG, blood pressure and movement capture). The skin colour of each participant will be categorized based on Fitzpatrick scale and non-invasive spectroscopic method.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children (0 to 18 years old) admitted in St. Justine's Hospital's PICU.
PICU monitoring for the next 24 hours
Disqualifiers
Recent cardiac or thoracic surgery
Thoracic skin lesion that contraindicates the VT-Patch
No parental consent
Intermittent presence of one study observer in the patient room is considered inappropriate by the physician or the nurse in charge because of the child's medical condition
Trial design
Design model
Single group
Treatments tested in this trial
Monitoring with VT-Patch (Connected device manufactured by VitalTracer)
DevicePatients will be monitored for 8 consecutive hours and vital signs will be recorded with VT-Patch and with the standard of care
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Monitored childrenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SpO2
Percentage of the difference between the absolute value of SpO2 recorded by VT-Patch and the one recorded using standard of care
Time frame
8 hoursSecondary outcomes
1
Heart rate
Percentage of the difference between the absolute value of heart rate recorded by VT-Patch and the one recorded using the standard of care
Time frame
8 hours2
Respiratory rate
Percentage of the difference between the absolute value of respiratory rate recorded by VT-Patch and the one recorded using standard of care
Time frame
8 hours3
Temperature
Percentage of the difference between the absolute value of temperature recorded by VT-Patch and the one recorded using standard of care
Time frame
8hoursSponsors and contacts
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Source ClinicalTrials.gov