Utilizing Home Pulse Oximetry for Patients With COVID-19 To Monitor Disease Progression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 209
- Locations
- 2
- Primary Endpoint
- Hospitalization in COVID-19 patients with low home SpO2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Hospitalization in COVID-19 patients with low home SpO2
Time Frame: 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 Outcomes
- Trend in resting home pulse oximetry readings(7 days after enrollment)
- Timing of SpO2 <92%(7 days after enrollment)
- Home pulse oximeter use effect on subsequent ED visits(7 days after enrollment)
- Reason for return to the Emergency Department(7 days after enrollment)
- Hospitalization outcome - morbidity(Up to 21 days after enrollment)
- Hospitalization outcome - mortality(Up to 21 days after enrollment)
- Median Length of Stay(Up to 21 days after enrollment)
Investigators
Kaushal Majmudar
Physician
Swedish Hospital