Home Pulse Oximeter Use in Patients With COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; COVID; Sars-CoV2
• Intervention / Treatment: Device: Home Pulse Oximetry Monitoring

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 Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60625
      • Swedish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Suspected COVID-19 patients being discharged to home; 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; Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen <92% or for worsening symptoms.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swedish Hospital
• Investigators: Study Director: Sonia Shah, DO, Swedish Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2020
• Primary Completion (ACTUAL): April 22, 2020
• Study Completion (ACTUAL): April 22, 2020

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (ACTUAL): May 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Oximeter; Oximetry
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020032301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes