Pulse Oximeter Calibration Clinical Trial
— NOSCSOfficial title:
NightOwl SpO2 Calibration Study
Calibration of a software module that computes Oxygen saturation(SpO2) based on
photoplethysmography (PPG) traces acquired by the NightOwl reflectance-based PPG sensor which
is placed on the finger.
The study is designed in accordance with Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of pulse oximeter equipment (ISO
80601- 2-61:2011)
Status | Recruiting |
Enrollment | 12 |
Est. completion date | January 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Healthy subjects with American Society of Anaesthesiologists health score (ASA) of 1 or 2, upon signing of informed consent. - 15% of the study population or 2 subjects (whichever is larger) with dark pigmented skin should be included in the study Exclusion Criteria: - smokers or individuals exposed to high levels of carbon monoxide that result in elevated carboxyhemoglobin levels. - individuals subject to conditions that result in elevated levels of methaemoglobin. individuals with arterial cannulation or hypoxia at FiO2 = 0,21 |
Country | Name | City | State |
---|---|---|---|
Belgium | CMC | Genk | Limburg |
Lead Sponsor | Collaborator |
---|---|
Ectosense NV |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A_rms determination | After calibration of the NightOwl SpO2 software module, the A_rms metric will be computed. This metric constitutes the performance metric proposed by ISO 80601-2-61:2011 Annex CC: Determination of accuracy. This metric captures the bias and precision of the computed SpO2 values compared to the benchmark. | Within 3 months after subject recruitment, the calibration and A_rms determination should have been performed |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03774199 -
NightOwl Pulse Oximeter Calibration Study
|
N/A |