This study aims to test the oxygen saturation component of the newly developed NeWTS monitoring system and compare readings from NeWTS to a traditional wired clinical monitor. It is important the investigators do this study in healthy adults as part of the development of this system, to make sure the oxygen saturation readings are accurate and before NeWTS is used in Neonatal Intensive Care (NICU).
The aim of the controlled desaturation study is to show that the NeWTS device can safely measure blood oxygen content in comparison to the "gold-standard" method of measuring blood oxygen levels (SaO2). To assess this, blood oxygen levels will be measured while the amount of oxygen participants breathe is gradually reduced. Healthy adults will start breathing oxygen at the same levels as in room air (21% oxygen) and this will be gradually reduced. The measurements from the NeWTS device will be compared to the value taken directly from the blood via an arterial line (SaO2). The SaO2 is measured by obtaining multiple blood samples from an artery in the body. As described in EN ISO 80601-2-61:2026 a minimum of 24 participants will be recruited with an average of 20 (±4), range 16-30 data points per participant. The investigators will include a distribution of data pairs, with total pairs split across each desaturation decade between 70 % to 100 % saturations, with approximately 33 %, but no less than 25 %, in each decade. 90 % or greater of participants shall provide at least one useable data pair with an SaO2 below 85 %. At least 75 % of participants shall also have provided at least one useable data pair with an SaO2 between 70 % to 80 %. The number of data pairs for a given SaO2 decile (i.e. 70 % to 80 %, 80 % to 90 % and 90 % to 100 %) will be derived approximately equally from participants across skin pigment categories, ensuring that \>25 % of data points come from light, medium and dark participants by MST and ITA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
24
The primary objective for this clinical investigation is to validate the SpO2 performance of the NeWTS in comparison to "gold-standard" measurements of blood SaO2 by a calibrated and QC'ed ABL90 Flex plus blood gas analyser.
Clinical Research Facility
Birmingham, England, United Kingdom
Validation of SpO2 performance
Validation of the SpO2 performance of the NeWTS in comparison to "gold standard" measurements of blood SaO2 by a calibrated and QC'ed ABL90 Flex plus blood gas analyser.
Time frame: From enrolment to end of study 3-4 hours
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