COVID, COVID-19, Sars-CoV2
Conditions
Keywords
Oximetry, Oximeter, COVID-19
Brief summary
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
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.
Interventions
Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen \<92% or for worsening symptoms.
Sponsors
Swedish Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization in COVID-19 patients with low home SpO2 | 7 days after enrollment | The primary outcome is the relative risk of hospitalization in COVID-19 patients with resting home pulse oximeter SpO2 below 92%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timing of SpO2 <92% | 7 days after enrollment | 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. |
| Home pulse oximeter use effect on subsequent ED visits | 7 days after enrollment | 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 |
| Reason for return to the Emergency Department | 7 days after enrollment | 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 |
| Trend in resting home pulse oximetry readings | 7 days after enrollment | 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 |
| Hospitalization outcome - mortality | Up to 21 days after enrollment | The study will assess mortality defined as death after admission to the hospital in patients with SpO2 \<92% |
| Median Length of Stay | Up to 21 days after enrollment | The study will measure median length of stay in patients with COVID-19 that are hospitalized on subsequent return to the ED. |
| Hospitalization outcome - morbidity | Up to 21 days after enrollment | 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% |
Countries
United States
Outcome results
None listed