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临床试验/NCT04529408
NCT04529408已完成不适用

EARSATS-19: In-ear Measurement of Blood Oxygen Saturation in COVID-19 Follow up

Imperial College London1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
In-Ear vs finger SpO2

研究概览

简要总结

TITLE EARSATS-19: In-ear measurement of blood oxygen saturation in COVID-19 follow up

DESIGN Non-inferiority study

AIMS To evaluate qualitative and quantitative performance of in-ear SpO2 monitoring against the gold standard right finger-clip pulse oximeter -- towards validation for use in COVID-19 in the acute ambulatory and long-term monitoring setting

OUTCOME MEASURES

In-ear SpO2 compared with gold-standard finger-clip pulse oximeter:

Correlation between SpO2 measurements at rest Correlation between SpO2 measurements during 6 minute walk test Signal quality during 6 minute walk test Qualitative evaluation of clinical and patient user acceptability using questionnaires

POPULATION 30 patients attending COVID-19 follow-up clinic and 30 patients with chronic lung disease attending routine outpatient investigations

ELIGIBILITY Aged 18 and above, no upper age limit Able to give informed consent No abnormal ear anatomy.

DURATION 12 months

详细描述

Non-invasive ambulatory estimation of blood oxygen saturation (SpO2) has emerged as an important clinical requirement to detect hypoxia (low blood oxygen) in the delayed post-infective phase of COVID- 19, where dangerous hypoxia may occur in the absence of subjective breathlessness. This now commonly termed 'silent' hypoxia presents an immediate clinical driver.

The COVID-19 pandemic places substantial pressure on clinical resources with ambulatory patients who were often discharged home to be cared for on virtual wards with daily telephone consults. Now the initial surge has settled, we are beginning to understand the challenge of following up patients who have had COVID-19 at volumes that mean doing this in a timely fashion is not possible (BTS Guidance 6 weeks).

There is mounting concern that the huge number of COVID-19 survivors will be at increased risk of chronic lung diseases such as pulmonary fibrosis, where early capture of patterns of low SpO2 could unearth desperately needed insights for preventing disease progression. The inconveniences, impracticalities and inaccuracies of conventional measurement of SpO2 (the percentage unit of blood oxygen) using a conventional finger probe for discrete readings are well established. A user-friendly, remote continuous SpO2 monitoring tool would therefore allow the rapid identification of any deterioration post discharge and also track longer-term recovery, allowing the accurate triage of patients to limited follow up resources.

Hearables and In-Ear Photoplethysmography

Reflective photoplethysmography (PPG), which uses a changes in the ratio between red and infrared light to estimate SpO2, can be measured from any site with skin that has vasculature, but for SpO2 measurement has conventionally been from fingers or sometimes the earlobe. The recent interest in the development of Hearables9 has promoted the ear canal as a preferred site for the measurement of vital signs in digital health technology. Indeed, the ear canal, which acts as a shield from external electrical noise (resembling a nature-built Faraday cage), represents a unique opportunity for physiological measurements, due to its general fixed position relative to the heart (ear-electrocardiogram) and proximity to the brain (ear-electroencephalogram). Relative to limbs, the head moves less in daily life and this is one property that has helped establish the feasibility of wearables to detect Ear-ECG and Ear-EEG.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients attending respiratory clinic either for COVID-19 follow up or for chronic lung disease.
  • Able to give informed consent (where not able to use CIE, paper consent form will be made available)

排除标准

  • Abnormal ear canal anatomy

结局指标

主要结局

In-Ear vs finger SpO2

时间窗: 12 months for full participant recruitment (actual head-to head comparison takes 1 minute for baseline reading and 6 minutes for 6-min walk test per patient)

Mean error and root mean square error; measurements for statistical significance using a paired t-test.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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