The primary objective of the study is to explore and compare the signal strength of different probes for measuring pulse oximetry signals on different body locations. The secondary objective of the study is comparing aspects of user experience (via…
ID
Source
Brief title
Condition
- Other condition
- Respiratory tract infections
Synonym
Health condition
geen aandoening, onderzoek met gezonde deelnemers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is achieved when the signal strength for each probe (belly,
forehead, finger, and heel) in each age category (0-2 months, 2-36 months, and
36-60 months) is determined in order to compare the signal strength with our
reference value from the null-hypotheses H0: the signal strength is 0.4%. The
signal strength is defined as the pulse height of the infrared light divided by
its slowly-varying baseline.
Secondary outcome
The secondary endpoint is achieved when the user aspects per probe and age
group are determined to a level that any frequently occurring disadvantage of a
probe would be identified.
Background summary
Pneumonia is the leading cause of death in children under the age of 5. Rapid
breathing is one of the signs of pneumonia, but this is often not enough to
correctly asses the disease. Determining the level of the oxygen saturation can
help confirm and assess the severity of the disease and take better treatment
decisions.
Study objective
The primary objective of the study is to explore and compare the signal
strength of different probes for measuring pulse oximetry signals on different
body locations. The secondary objective of the study is comparing aspects of
user experience (via observations and interviews) of different pulse oximeter
probes on healthy children from 0 to 5 years.
Study design
This study is designed as a data collection and observational study. Different
probe designs, technologies and body locations are tested.
After the intake and the informed consent procedure, the child is weighed to
select the reference probe. A camera will be set to obtain a good view of the
subject and the reference probe will be attached to the child*s finger. The
new-design probe will be attached to the child; the data will be collected for
5 minutes. The new-design probe will be removed and the procedure will be
repeated until all new-design probes are tested. The order of the probes will
be randomized with every subject. On six of the 36 subjects only mock-ups will
be tested on user experience and one size fits all aspect of the mock-up.
Study burden and risks
In the study there is no benefit for the subjects. There is future benefit to
the study population, although in low resource settings. When future population
receives the right diagnosis and applicable treatment of the disease, this will
result in saving their lives.
The risks associated with participation in this study can be considered
negligible since all potential risks, including electrical hazards which may
come from parts/devices of the setup, and cross-contamination, are properly
mitigated. Also, the burden can be considered minimal, since the sensors are
developed in such a way they are safe and minimally invasive. The aim of the
study is to collect data on PPG signals from young children of 0-5 years old
and to develop a single sensor for this age category. The study will also gain
insights in usability of the sensor and the body location of the measurement.
Hence, the study can only be carried out with this target group, since their
behaviour and body characteristics are clearly distinct from other age groups.
High Tech Campus 34
Eindhoven 5656AE
NL
High Tech Campus 34
Eindhoven 5656AE
NL
Listed location countries
Age
Inclusion criteria
Healthy children between 0 - 5 years, Indian and African heritage would be preferred but not mandatory, since the probe would be targeting India and Africa.
Exclusion criteria
Subjects carrying or wearing any supportive or medical device in the area that the probe is going to be placed or subjects missing or with a physical deformity in that extremity (feet or finger).
Subjects with childhood asthma, cardiovascular diseases, heart murmur or any type of medication (excluding medication without a prescription).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL54092.015.15 |