Automated spot-check respiration and pulse monitoring for 5-18 year old patients

Hospital scoring systems like the Early Warning Score (EWS) offer a simple
guide for nursing & medical staff to quickly determine the degree of illness of
a patient by combining their vital signs into one single composite score. It
has been shown that using such scoring system on general wards can reduce the
number of unexpected intensive care admissions by 70% thanks to early detection
of patient deterioration. On pediatric wards, the use of Pediatric Early
Warning Scoring (PEWS) has the potential to greatly enhance patient safety.
The patient*s heart rate and respiration rate are two of the vital signs that
are included in the PEWS system. Measuring these parameters from 5-18 years old
patients multiple times a day requires significant nurse effort, patience of
the patient (sit still during counting) and/or involves wired monitoring. A
method that would allow getting an automated reading on both the heart rate and
respiration rate in a wireless and unobtrusive manner would make the life of
both nurses and patients easier and more comfortable, while improving the
patient*s safety by monitoring their vital signs.

This clinical investigation is designed to evaluate whether respiration rate
and heart rate from pediatric patients (5-18 years) can be measured accurately
using thoracic motion data
This study is designed to collect data for testing of the respiration rate and
pulse rate detection algorithm, implemented in the Philips IntelliVue CL
Respiration Pod, for use with 5-18 years old patients. The data collected using
the motion sensor of this study will be compared with the one obtained using
the golden standard for respiratory frequency ( by using a respiration band)
and heart rate (by using ECG) .

A total number of two investigational devices will be used in this study.
These are: the Respiration pod prototype with the datalogger and the slightly
modified transducer band. The Respiration pod prototype contains the motion
sensors, while the datalogger stores the acquired data from the motion sensors,
transducer band and ECG. The transducer band is a slightly modified version of
a commercially available, CE-approved device. The modification concerns the
connection of pressure studs for connecting the band to the datalogger.

Wearing the measurement apparatus may cause some discomfort.

All risks are mitigated to acceptable levels.
Further information can be found in the chapter 11 of the Research protocol.