SurePulse Oximeter - a Targeted Oxygenation Observation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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SurePulse Oximeter - a Targeted Oxygenation Observation: A Controlled Desaturation Study to Establish the Accuracy and Precision of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP)

Conditions
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Healthy

Intervention / Treatment
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* Device: SurePulse VSP
* Device: SurePulse VS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 55 Willing and able to provide written informed consent Healthy adult subjects (ASA 1) Non-smoker Willing and able to comply with study procedures and duration Exclusion Criteria: Smokers or individuals exposed to high levels of carbon monoxide Compromised circulation, injury, or physical malfunction of the sensor sites which would limit the ability to test sites needed for the study Female subjects that are actively trying to get pregnant or are pregnant (conﬁrmed by Health Assessment Form). N.B. All female participants will be offered a pregnancy test Unwillingness or inability to remove coloured nail polish from test digits (relevant for reference pulse oximeter) or to have medical monitoring attached Known health conditions disclosed on Health Assessment Form which mean that participant is not healthy Allergy to lidocaine Allergy to adhesives used in medical dressings or tapes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: A controlled and stepwise reduction in oxygen blood levels, with both the SurePulse VS and SurePulse VSP placed on the volunteer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SurePulse VS and VSP devices<br>All enrolled participants will undergo a controlled and stepwise reduction in oxygen blood levels, with both the SurePulse VS/SurePulse VSP placed on the volunteer. | Device: SurePulse VSP<br>* A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VSP placed on the volunteer.<br>Device: SurePulse VS<br>* A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VS placed on the volunteer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Through study completion, an average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Through study completion, an average of 2 hours | 
| 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. | Through study completion, an average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoxia, Oxygen Saturation, Pulse Oximetry