This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS Patch (VSP) are for measuring blood oxygen levels (oxygen saturation). If the results are accurate, the VSP will be ready to apply for regulatory approval, meaning it could then be available for use on newborn babies in the National Health Service (NHS).
Healthy volunteers who express an interest in the study and meet the eligibility criteria will be invited to participate in the study. This study will investigate the accuracy and safety of the SurePulse VS and SurePulse VS Patch (VSP) in measuring blood oxygen levels. This is done by measuring blood oxygen levels across a range of values in healthy adults. The measurements from the VS and VSP will be compared to the known correct value. The study follows the internationally agreed standard for pulse oximeter approval. Agreeing participants will have their name, contact details, medical history, height, weight, date of birth, skin colour, emergency contact details and address recorded, as necessary to conduct the study. After completion of the eligibility and consent process, participants will be enrolled in the study. Healthy volunteers will have their blood oxygen levels temporarily reduced in a controlled and stepwise manner. Oxygen levels will not be low for the entire duration of the session. Oxygen levels will be reduced to a specific target for a few minutes at a time. Volunteers will have a small tube inserted into an artery (blood vessel) in their wrist; this will be used to take blood samples throughout the session. The blood samples will be taken, analysed and destroyed in the same room. The session should take approximately 1.5 - 2 hours in total. The output from the study will be compared to the primary and secondary outcomes to evaluate the performance and safety of the device. This study is required for the SurePulse VSP to be regulatory approved, meaning it could then become available in the NHS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
19
A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VSP placed on the volunteer.
A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VS placed on the volunteer.
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Validation of the SpO2 accuracy of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP) pulse oximeter in comparison to "gold-standard" measurements of blood SaO2 by a co-oximeter.
Oxygen saturation comparison of measurements taken by the SurePulse VSP (SpO2) and co-oximeter blood gas analyser (SaO2). For the statistical analysis, the Accuracy Root Mean Square (Arms) calculation is used to determine the SpO2 accuracy performance.
Time frame: Through study completion, an average of 2 hours
Adverse events (AEs) attributable to the SurePulse medical devices
Incidence, severity and causality of all AEs with delineation of those that are attributable to the use of the SurePulse medical devices to be used as a measure of device safety. Safety is measured by adverse events attributable to SurePulse medical devices and will be measured by adverse event logs and reports and their associated reporting requirements.
Time frame: Through study completion, an average of 2 hours
Validation of the SpO2 accuracy of the SurePulse VS Monitor (VS) in comparison to "gold-standard" measurements of blood SaO2 by a co-oximeter.
Oxygen saturation comparison of measurements taken by the SurePulse VS (SpO2) and co-oximeter blood gas analyser (SaO2). For the statistical analysis, the Accuracy Root Mean Square (Arms) calculation is used to determine the SpO2 accuracy performance.
Time frame: Through study completion, an average of 2 hours
Validation of the pulse rate accuracy of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP) pulse oximeter in comparison to ECG.
Pulse Rate comparison of measurements taken by the SurePulse VSP and ECG. For the statistical analysis, the Accuracy Root Mean Square (Arms) calculation is used to determine the Pulse Rate accuracy performance.
Time frame: Through study completion, an average of 2 hours
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Validation of the pulse rate accuracy of the SurePulse VS Monitor (VS) in comparison to ECG.
Pulse Rate comparison of measurements taken by the SurePulse VS and ECG. For the statistical analysis, the Accuracy Root Mean Square (Arms) calculation is used to determine the Pulse Rate accuracy performance.
Time frame: Through study completion, an average of 2 hours