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Completed

NCT Number: NCT05756816

SurePulse Oximeter - a Targeted Oxygenation Observation

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).

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Key information

Conditions

Healthy Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SurePulse VSP

Device

A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VSP placed on the volunteer.

SurePulse VS

Device

A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VS placed on the volunteer.

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 2 hours

    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.

  2. Adverse events (AEs) attributable to the SurePulse medical devices

    Time frame: Through study completion, an average of 2 hours

    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.

Secondary outcomes

  1. Validation of the SpO2 accuracy of the SurePulse VS Monitor (VS) in comparison to "gold-standard" measurements of blood SaO2 by a co-oximeter.

    Time frame: Through study completion, an average of 2 hours

    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.

  2. Validation of the pulse rate accuracy of the SurePulse VS Patch Newborn Vital Sign Monitor (VSP) pulse oximeter in comparison to ECG.

    Time frame: Through study completion, an average of 2 hours

    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.

  3. Validation of the pulse rate accuracy of the SurePulse VS Monitor (VS) in comparison to ECG.

    Time frame: Through study completion, an average of 2 hours

    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.

Sponsors and collaborators

Lead sponsor

Surepulse Medical Limited

Industry

Collaborators

  • University Hospital Birmingham NHS Foundation Trust

Registry information

Official study title

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)

Acronym: SPO-TOO

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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