Home Pulse Oximeter Use in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373161
• Other study ID #: 2020032301
• Status: Completed
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: April 22, 2020

Study information

• Verified date: May 2020
• Source: Swedish Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: April 22, 2020
• Est. primary completion date: April 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID
• COVID-19
• Sars-CoV2

Intervention

Device:
• Home Pulse Oximetry Monitoring
Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen <92% or for worsening symptoms.

Locations

Country	Name	City	State
United States	Swedish Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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