Home Pulse Oximeter Use in Patients With COVID-19

Study Overview
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Brief Summary
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The purpose of this study is to investigate the use of home pulse oximetry monitoring in patients with COVID-19 to trend disease progression and identify need for hospitalization.

Detailed Description
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This protocol studies patients with suspected non-severe Corona Virus Disease (COVID-19) being discharged to home from an emergency department (ED) or outpatient testing center. Patients will be provided a portable fingertip home pulse oximeter that measures peripheral oxygen saturation (SpO2). Patients will be instructed to check their resting home oxygen saturation three times per day and record these findings. They will be instructed to return to the emergency room for sustained oxygen saturation below 92% or if their symptoms are worsening and they feel they need medical attention. Patients will be called once daily by the research team to collect data in real time. Patients will be monitored for seven days, and at the end of the seven day period, they will return the pulse oximeter as well as a spreadsheet of their home oximetry readings. The purpose is to see if home pulse oximetry identifies disease progression and need for hospitalization in patients with COVID-19. Additionally, there will be analysis of trends in home oximetry readings wand predictors of morbidity and mortality.

Official Title
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Utilizing Home Pulse Oximetry for Patients With COVID-19 To Monitor Disease Progression

Conditions
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COVID, Sars-CoV2, COVID-19

Intervention / Treatment
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* Device: Home Pulse Oximetry Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with suspected COVID-19 as defined by the World Health Organization Age > 18 Exclusion Criteria: Pregnancy Prisoners Lack of decision making capacity or cannot provide consent Patients being admitted to the hospital Patients on home oxygen Patients being discharged to a skilled nursing facility

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suspected COVID-19 patients being discharged to home<br>Patients will be given a portable, fingertip pulse oximeter to take home. Patients will monitor their resting home oxygen saturation three times per day. | Device: Home Pulse Oximetry Monitoring<br>* Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen <92% or for worsening symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization in COVID-19 patients with low home SpO2 | The primary outcome is the relative risk of hospitalization in COVID-19 patients with resting home pulse oximeter SpO2 below 92%. | 7 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trend in resting home pulse oximetry readings | The purpose of this outcome is to determine if home pulse oximetry readings abruptly drop, gradually decline, or stay level in patients with COVID-19 | 7 days after enrollment | 
| Timing of SpO2 <92% | This will evaluate if there is a correlation between the time of day with SpO2 readings below 92 percent in patients with suspected COVID-19. | 7 days after enrollment | 
| Home pulse oximeter use effect on subsequent ED visits | The goal of this outcome is to see if patients enrolled in the study are reassured by use of home pulse oximeter monitoring and if this device prevents subsequent ED visits by patients | 7 days after enrollment | 
| Reason for return to the Emergency Department | To see if patients who return to the ED and end up hospitalized did so for incidental finding of low home pulse oximetry or if it was for worsening symptoms | 7 days after enrollment | 
| Hospitalization outcome - morbidity | The study will assess development of morbidity defined as intensive care unit admission, acute respiratory distress syndrome, and/or septic shock in patients with SpO2 <92% | Up to 21 days after enrollment | 
| Hospitalization outcome - mortality | The study will assess mortality defined as death after admission to the hospital in patients with SpO2 <92% | Up to 21 days after enrollment | 
| Median Length of Stay | The study will measure median length of stay in patients with COVID-19 that are hospitalized on subsequent return to the ED. | Up to 21 days after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oximetry, Oximeter, COVID-19