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临床试验/NCT04647747
NCT04647747已完成不适用

Silent Hypoxia and Awake Proning in COVID-19 Patients: Home Monitoring and Self-Reporting

Ostfold Hospital Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Association between silent hypoxia and other subjective and objective measurements of disease severity

研究概览

简要总结

The Investigators want to examine patients infected with SARS-CoV-2 for the phenomenon "Silent Hypoxia", which is clinically significant hypoxia without corresponding degree of dyspnea. The patient population is infected individuals without any serious symptoms and is at home. The participants will be equipped with a pulse oximeter and a PEF-measurement device. Four times daily the participants will register saturation, degree of dyspnea and PEF. If the participants experience desaturation or increasing dyspnea, physiotherapy is to be performed, and if that doesn't relieve symptoms or increase oxygen saturation, the hospital should be contacted for admission. The first part of this study is a feasibility study, and if found feasible, the investigators will expand the study to more participants.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Non dyspneic (NRS =/< 1) patients with positive SARS-CoV-2 test
  • •Age 18 - 80 years
  • •Patients managed at home
  • •Inclusion within 72 hours from positive test

排除标准

  • •Chronic hypoxia (SpO2 < 93 %) and/or first measured SpO2 < 93 %
  • •Admitted to hospital for COVID-19 prior to inclusion
  • •Unable to perform pulse oximetry
  • •Unable to perform physiotherapy

研究组 & 干预措施

Self measurement of peripheral saturation

Other

Participant will be equipped with a pulse oximeter and perform saturation measurements.

干预措施: Self measurement with pulse oximeter (Other)

结局指标

主要结局

Association between silent hypoxia and other subjective and objective measurements of disease severity

时间窗: January 30, 2021

Number of patients who manage to perform daily measurements of SpO2

时间窗: January 30, 2021

Incidence rate of silent hypoxia in non-hospitalized COVID-19

时间窗: January 30, 2021

次要结局

  • Effect of a self-managed physiotherapy program on alleviating hypoxia(January 30, 2021)
  • Rate of hospital admission and ICU admission(January 30, 2021)
  • Incidence of thromboembolic event in outpatients diagnosed with COVID-19(January 30, 2021)
  • Rate of persistent silent hypoxia episode per patients(January 30, 2021)
  • Rate of silent hypoxia episode per patients(January 30, 2021)

研究者

发起方
Ostfold Hospital Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hans Joakim Myklebust-Hansen

Konstituert Overlege, Akuttseksjonen

Ostfold Hospital Trust

研究点 (1)

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