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Exploration of SpO2 probe for low resource settings

Exploration of SpO2 probe for low resource settings - Diagnostics solutions for low-resource settings

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42710
Enrollment
36
Registered
2015-07-29
Start date
2015-09-24
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

geen aandoening, onderzoek met gezonde deelnemers nvt

Interventions

None listed

Sponsors

Philips Research
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)