SurePulse Oximeter - a Targeted Oxygenation Observation

NCT ID: NCT05756816

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2023-07-26

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).

Detailed Description

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

SurePulse VS and VSP devices

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.

Group Type: EXPERIMENTAL

SurePulse VSP

Intervention Type: DEVICE

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

SurePulse VS

Intervention Type: DEVICE

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

Interventions

SurePulse VSP

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

Intervention Type: DEVICE

SurePulse VS

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Surepulse Medical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Murray du Plessis

Role: PRINCIPAL_INVESTIGATOR

University Hospital Birmingham NHS Foundation Trust

Locations

University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

MTT-ISG-INS-196

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

317814

Identifier Type: OTHER

Identifier Source: secondary_id

VSP-CI-01

Identifier Type: -

Identifier Source: org_study_id