Controlled Oxygen Desaturation Study of the Neonatal Wireless Transmission System (NeWTS-DS)
Controlled Oxygen Desaturation Study of the Neonatal Wireless Transmission System (NeWTS): NeWTS-DS
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Kathryn Beardsall, MD
- Phone Number: +447565 964631
- Email: kb274@cam.ac.uk
Study Contact Backup
- Name: Catherine Guy, BSc(Hons)
- Email: cc570@cam.ac.uk
Study Locations
-
-
England
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Birmingham, England, United Kingdom, B15 2GW
- Clinical Research Facility
-
Contact:
- Conor Jones, MSc
- Phone Number: +447443264198
- Email: newts.hrcddr@uhb.nhs.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Controlled Oxygen Desaturation of Healthy Adult Volunteers
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validation of SpO2 performance
Time Frame: 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.
|
From enrolment to end of study 3-4 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kathryn Beardsall, MD, University of Cambridge
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A097812
- NIHR206500 (Other Grant/Funding Number: NIHR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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