Device Performance, Testing Accuracy
Conditions
Keywords
Neonatal Wireless Transmission System (NeWTS), Controlled oxygen desaturation
Brief summary
This study aims to test the oxygen saturation component of the newly developed NeWTS monitoring system and compare readings from NeWTS to a traditional wired clinical monitor. It is important the investigators do this study in healthy adults as part of the development of this system, to make sure the oxygen saturation readings are accurate and before NeWTS is used in Neonatal Intensive Care (NICU).
Detailed description
The aim of the controlled desaturation study is to show that the NeWTS device can safely measure blood oxygen content in comparison to the "gold-standard" method of measuring blood oxygen levels (SaO2). To assess this, blood oxygen levels will be measured while the amount of oxygen participants breathe is gradually reduced. Healthy adults will start breathing oxygen at the same levels as in room air (21% oxygen) and this will be gradually reduced. The measurements from the NeWTS device will be compared to the value taken directly from the blood via an arterial line (SaO2). The SaO2 is measured by obtaining multiple blood samples from an artery in the body. As described in EN ISO 80601-2-61:2026 a minimum of 24 participants will be recruited with an average of 20 (±4), range 16-30 data points per participant. The investigators will include a distribution of data pairs, with total pairs split across each desaturation decade between 70 % to 100 % saturations, with approximately 33 %, but no less than 25 %, in each decade. 90 % or greater of participants shall provide at least one useable data pair with an SaO2 below 85 %. At least 75 % of participants shall also have provided at least one useable data pair with an SaO2 between 70 % to 80 %. The number of data pairs for a given SaO2 decile (i.e. 70 % to 80 %, 80 % to 90 % and 90 % to 100 %) will be derived approximately equally from participants across skin pigment categories, ensuring that \>25 % of data points come from light, medium and dark participants by MST and ITA.
Interventions
DEVICENeonatal Wireless Transmission System
The primary objective for this clinical investigation is to validate the SpO2 performance of the NeWTS in comparison to "gold-standard" measurements of blood SaO2 by a calibrated and QC'ed ABL90 Flex plus blood gas analyser.
Sponsors
Kathryn Beardsall
National Institute for Health Research, United Kingdom
University of Cambridge
University Hospital Birmingham NHS Foundation Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Be aged 18-55 years * Willing and have capacity to provide written informed consent * Healthy adult volunteers classified as ASA 1 * Non-smoker (this does not exclude vaping) * Willing and able to comply with study procedures and duration
Exclusion criteria
* History of Bleomycin treatment at any time * 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 * Morbidly obese (defined as BMI \>39.5) or significantly underweight (BMI \<18) * Pregnancy * Participants who can conceive a pregnancy or carry a child (including women, trans men and non-binary people) will be required to demonstrate a negative pregnancy test * Unwillingness or inability to remove coloured nail polish or nail attachments from test digits (relevant for reference pulse oximeter) or to have medical monitoring attached * Known health conditions or medications disclosed on Health Assessment Form which mean that participant is not healthy * Allergy to lidocaine * Known allergy to adhesives used in medical dressings or tapes or materials used to adhere NeWTS components. * Enrolment in any other clinical investigation/trial that is deemed would compromise the validity of the data or safety of the patient (at the discretion of the local PI) * Sunburn/spray tan or other pigments on hands
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of SpO2 performance | From enrolment to end of study 3-4 hours | Validation of the SpO2 performance of the NeWTS in comparison to "gold standard" measurements of blood SaO2 by a calibrated and QC'ed ABL90 Flex plus blood gas analyser. |
Countries
United Kingdom
Contacts
CONTACTKathryn Beardsall, MD
CONTACTCatherine Guy, BSc(Hons)
PRINCIPAL_INVESTIGATORKathryn Beardsall, MD
University of Cambridge
Outcome results
None listed