Silent Hypoxia and Awake Proning in COVID-19 Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Covid19, Hypoxemia

Intervention / Treatment
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* Other: Self measurement with pulse oximeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Self measurement of peripheral saturation<br>Participant will be equipped with a pulse oximeter and perform saturation measurements. | Other: Self measurement with pulse oximeter<br>* Participant will measure peripheral saturation at home, conduct physiotherapy if desaturation occurs, and contact hospital if desatuation persists<br>* Other names: Lung physiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who manage to perform daily measurements of SpO2 |  | January 30, 2021 | 
| Incidence rate of silent hypoxia in non-hospitalized COVID-19 |  | January 30, 2021 | 
| Association between silent hypoxia and other subjective and objective measurements of disease severity |  | January 30, 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of a self-managed physiotherapy program on alleviating hypoxia |  | January 30, 2021 | 
| Rate of persistent silent hypoxia episode per patients |  | January 30, 2021 | 
| Rate of silent hypoxia episode per patients |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silent Hypoxia, Lung Physiotherapy, Home Monitoring