Clinical trial NCT04373161: Home Pulse Oximeter Use in Patients With COVID-19
Official title: Utilizing Home Pulse Oximetry for Patients With COVID-19 To Monitor Disease Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sars-CoV2
COVID-19
COVID
Keywords: Oximetry
Oximeter
COVID-19
Lead sponsor: Swedish Hospital
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization in COVID-19 patients with low home SpO2
timeFrame: 7 days after enrollment
Secondary outcomes:
measure: Trend in resting home pulse oximetry readings
timeFrame: 7 days after enrollment
measure: Timing of SpO2 <92%
timeFrame: 7 days after enrollment
measure: Home pulse oximeter use effect on subsequent ED visits
timeFrame: 7 days after enrollment
measure: Reason for return to the Emergency Department
timeFrame: 7 days after enrollment
measure: Hospitalization outcome - morbidity
timeFrame: Up to 21 days after enrollment
measure: Hospitalization outcome - mortality
timeFrame: Up to 21 days after enrollment
measure: Median Length of Stay
timeFrame: Up to 21 days after enrollment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Swedish Hospital
state: Illinois
Study officials:
affiliation: Swedish Hospital
name: Sonia Shah, DO
role: STUDY_DIRECTOR
References: