CompletedNot Applicable

SurePulse Oximeter - a Targeted Oxygenation Observation

United Kingdom19 participantsStarted 2023-04-27

Plain-language summary

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).

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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.

Timeframe: Through study completion, an average of 2 hours

Adverse events (AEs) attributable to the SurePulse medical devices

Timeframe: Through study completion, an average of 2 hours

Trial details

NCT IDNCT05756816

SponsorSurepulse Medical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-26

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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.

Timeframe: Through study completion, an average of 2 hours

Adverse events (AEs) attributable to the SurePulse medical devices

Timeframe: Through study completion, an average of 2 hours