Accuracy of Wrist-worn Pulse Oximeter SpO2 Measurements in Patients Diagnosed With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) at rest
研究概览
简要总结
The goal of this study is to learn how accurate smartwatches are at measuring oxygen levels in patients with a condition called pulmonary hypertension. The main questions it aims to answer are:
- How accurate the smartwatches are at measuring oxygen levels when the patient is sitting at rest
- How accurate are smartwatches at measuring oxygen levels after exercise
- How accurate are smartwatches at measuring oxygen levels after breathing a lower level of oxygen through a mask.
Researchers will compare oxygen levels measured through a smartwatch with those checked through a finger probe oxygen monitor and also from a blood sample checked from the artery in the wrist to see if smartwatch oxygen measurements are similar.
Participants will:
-Attend the hospital once, just for a few hours to collect all the required data.
详细描述
The goal of this pilot study is assess the accuracy of SpO2 measurements in smartwatches when compared to arterial oxygen levels and pulse oximeter readings at rest, following exercise and at simulated high altitude with the use of a hypoxic challenge test.
Patient recruitment:
Patients will be recruited prospectively from the Scottish Pulmonary Vascular Unit at the Golden Jubilee National Hospital, Glasgow, Scotland.
Patients attending outpatient clinic will be screened for eligibility. Additionally, a study poster will be displayed in the clinic waiting area. If eligible, patients will be asked if they would like to learn about the study. After discussing the study overview in person, the patient will be offered the patient information sheet to take away with them and advised that if they are interested in taking part or have any further questions about the study, they can either reply using the opt in form provided or by phoning the study team. Those patients who opt in to the trial will be contacted to provide them with a date to attend for a study visit.
On the day of the study visit, prior to commencing any study activities, participants will see a different doctor from the research team who will clarify their full understanding of the study and will give them the opportunity to complete the written study consent form.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-years old and above.
- •Diagnosed with pulmonary hypertension by right heart catheterisation showing a baseline mean pulmonary artery pressure > 20mmHg, PVR >2 Woods Units.
- •Able to perform a six-minute walk test (6MWT)
- •Able to give written informed consent.
排除标准
- •Peripheral arterial disease
- •Tattoos or skin markings which cover the dorsal wrist.
- •Resting SpO2 <88%
- •Severe concurrent medical condition that would prevent participation in study procedures or with life expectancy <3 months
- •Patients with bleeding disorders
- •Patients on anticoagulation
- •Except in circumstances where anticoagulation is given solely for historical perceived long term survival benefit for pulmonary arterial hypertension. This patient group could be given the option to come off their anticoagulation for 1 week prior to the study visit if they wished to take part in the study. It could then be restarted the day following the study visit providing there were no bleeding complications related to the arterial line.
研究组 & 干预措施
Adult patients with pulmonary hypertension
Pre-capillary pulmonary hypertension, able to complete a six-minute walk test
结局指标
主要结局
Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) at rest
时间窗: 1 study visit, anticipated to be around 3 hours.
SpO2 (measured by the wrist-worn pulse oximeter (smartwatch) and standard fingerprobe pulse oximeter) and SaO2 (measured by the arterial blood gas analysis) measured as a percentage.
次要结局
- 1. Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) after exercise(1 study visit, estimated 3 hours duration)
- 1. Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) after a hypoxic challenge(1 study visit, estimated 3 hours duration)