SurePulse Oximeter – a Targeted Oxygenation Observation (SPO-TOO)
Research type
Research Study
Full 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)
IRAS ID
317814
Contact name
Murray du Plessis
Contact email
Sponsor organisation
SurePulse Medical Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 27 days
Research summary
Monitoring blood oxygen levels is important in making sure that newborn babies receive suitable medical care. Current pulse oximeters, used to measure blood oxygen levels, can provide slow and inaccurate recordings.
SurePulse Medical Ltd has developed the SurePulse VS Patch (VSP) vital signs monitor to wirelessly monitor the blood oxygen levels of newborn babies. An accurate and reliable device could allow more suitable treatment to be provided. A wireless device may also allow parents to hold their baby whilst being monitored. This has been shown to improve health outcomes and allow families to leave hospital earlier. This will be placed on participant’s chest to investigate how accurate the VSP is for measuring blood oxygen levels.
Another device called the SurePulse VS (VS) is already used to wirelessly monitor heart rates of newborn babies. The sensor probe will be placed on participant’s foreheads to assess whether the device can also accurately measure blood oxygen levels.
This study aims to show that the VS and VSP are accurate in measuring blood oxygen levels. We will do this 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. This follows an internationally agreed standard (ISO ISO80601-2-61) which is required for the approval of all pulse oximeters. The study will also measure safety of the devices.
The study will recruit between 10 and 20 healthy adult volunteers, aged between 18 and 55-years-old. Participants will have their blood oxygen levels temporarily reduced in a controlled and stepwise manner. Study participation should take between 1.5-2 hours in total and will take place at the Queen Elizabeth Hospital, Birmingham.
If the results are accurate and the device is safe, the devices will be ready to apply for regulatory approval.
REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0699
Date of REC Opinion
25 Nov 2022
REC opinion
Further Information Favourable Opinion