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临床试验/NCT04565106
NCT04565106已完成不适用

Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年4月15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
16
试验地点
1
主要终点
Time in SpO2 target

研究概览

简要总结

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

详细描述

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

Patients were prospectively enrolled in an observational study on a medical ward dedicated to patients with COVID-19. Closed-loop controlled oxygen was delivered by O2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of SpO2 measured by pulse oximetry. Lung function parameters were measured at admission.

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

  • Older than 18 years
  • Positive COVID-19 PCR analysis in pharyngeal swab or in tracheal secretion
  • Need oxygen supply to maintain SpO2 ≥ 92 %
  • Able to comply with continuous measurement of SpO2 by pulse oximetry.

排除标准

  • Need of oxygen supply > 10 liters/min at admission

结局指标

主要结局

Time in SpO2 target

时间窗: 1 week

Time in SpO2 target of 92-96 %

次要结局

  • Time with SpO2 < 85 %(1 week)
  • Time with SpO2 not more than 2 % outside target(1 week)
  • Time with SpO2 more than 2 % outside target(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ejvind Frausing Hansen

Chief Physician

Hvidovre University Hospital

研究点 (1)

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