Controlled Oxygen Desaturation Study of the Neonatal Wireless Transmission System (NeWTS): NeWTS-DS
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Validation of SpO2 performance
研究概览
简要总结
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).
详细描述
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 %.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Controlled Oxygen Desaturation of Healthy Adult Volunteers
干预措施: Neonatal Wireless Transmission System (Device)
结局指标
主要结局
Validation of SpO2 performance
时间窗: 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.
次要结局
未报告次要终点
研究者
Kathryn Beardsall
Chief Investigator
Cambridge University Hospitals NHS Foundation Trust