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临床试验/NCT04668313
NCT04668313Unknown不适用

COVID-19 Advanced Respiratory Physiology (CARP) Study

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年9月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Machine-learning model development

研究概览

简要总结

The anticipated second wave of COVID-19 cases will present healthcare system challenges, including requirement to monitor large numbers of patients for deteriorating respiratory failure. Rising respiratory rate can identify deterioration requiring escalation of care. However constant monitoring of respiratory rate can be challenging outwith critical care units due to feasibility and inaccuracy of intermittent measurements.

Wearable biosensors which allows for remote patient monitoring of RR is therefore attractive, particularly when combined in a dashboard with clinical summary data. This would establish source data and infrastructure for the training and validation of machine-learning models, with decision support risk-predictions prioritising alerts and clinician reviews.

详细描述

Altair medical has developed a pre-commercial investigational wearable (chest-worn) biosensor which can measure continuous respiratory rate and respiratory events. This sensor has been verified to have good correlation with reference impedance plethysmography data.

Inclusion criteria:

All inpatients in the QEUH with respiratory failure from any cause.

Exclusion criteria:

Lack of capacity to consent

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Inclusion criteria
  • Adult patients with respiratory failure of any cause requiring hospital admission, oxygen therapy and routine NEWS-2 physiology observations.
  • CARP detailed sub-study Adult patients with respiratory failure who are suitable for opportunistically acquired serial detailed physiology measurements taken alongside routine clinical care by study team.
  • CARP follow-up remote-monitoring sub-study Adult patients with respiratory failure who have provided informed consent and have a smartphone to connect to Fitbit and Lenus accounts for postdischarge wearable device data capture.

排除标准

  • Exclusion criteria • Lack of capacity or inability to comprehend informed consent.

结局指标

主要结局

Machine-learning model development

时间窗: 1 year

Developing risk-predictions for clinically significant deteriorations

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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