SurePulse Oximeter - a Targeted Oxygenation Observation

NCT05756816 | Completed

• 3 other identifiers: VSP-CI-01MTT-ISG-INS-196317814
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy

Keywords

Hypoxia; Oxygen Saturation; Pulse Oximetry

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

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

  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.

  Through study completion, an average of 2 hours

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

  Through study completion, an average of 2 hours

Study Arms (1)

SurePulse VS and VSP devices

EXPERIMENTAL

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; Device: SurePulse VS

Interventions

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 and VSP devices

SurePulse VS DEVICE

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

SurePulse VS and VSP devices

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: There should be a minimum of 40% male and minimum of 40% female participants with the balance made up of either.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Surepulse Medical Limited: lead
• University Hospital Birmingham NHS Foundation Trust: collaborator

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Murray du Plessis

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A controlled and stepwise reduction in oxygen blood levels, with both the SurePulse VS and SurePulse VSP placed on the volunteer.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 6, 2023
• Study Start: April 27, 2023
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)