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Home Pulse Oximeter Use in Patients With COVID-19

Primary Purpose

Sars-CoV2, COVID-19, COVID

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home Pulse Oximetry Monitoring
Sponsored by
Swedish Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sars-CoV2 focused on measuring Oximetry, Oximeter, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Swedish Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suspected COVID-19 patients being discharged to home

Arm Description

Patients will be given a portable, fingertip pulse oximeter to take home. Patients will monitor their resting home oxygen saturation three times per day.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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
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.
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
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
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%
Hospitalization outcome - mortality
The study will assess mortality defined as death after admission to the hospital in patients with SpO2 <92%
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.

Full Information

First Posted
April 30, 2020
Last Updated
May 5, 2020
Sponsor
Swedish Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04373161
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
April 22, 2020 (Actual)
Study Completion Date
April 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swedish Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sars-CoV2, COVID-19, COVID
Keywords
Oximetry, Oximeter, COVID-19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suspected COVID-19 patients being discharged to home
Arm Type
Experimental
Arm Description
Patients will be given a portable, fingertip pulse oximeter to take home. Patients will monitor their resting home oxygen saturation three times per day.
Intervention Type
Device
Intervention Name(s)
Home Pulse Oximetry Monitoring
Intervention Description
Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen <92% or for worsening symptoms.
Primary Outcome Measure Information:
Title
Hospitalization in COVID-19 patients with low home SpO2
Description
The primary outcome is the relative risk of hospitalization in COVID-19 patients with resting home pulse oximeter SpO2 below 92%.
Time Frame
7 days after enrollment
Secondary Outcome Measure Information:
Title
Trend in resting home pulse oximetry readings
Description
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
Time Frame
7 days after enrollment
Title
Timing of SpO2 <92%
Description
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.
Time Frame
7 days after enrollment
Title
Home pulse oximeter use effect on subsequent ED visits
Description
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
Time Frame
7 days after enrollment
Title
Reason for return to the Emergency Department
Description
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
Time Frame
7 days after enrollment
Title
Hospitalization outcome - morbidity
Description
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%
Time Frame
Up to 21 days after enrollment
Title
Hospitalization outcome - mortality
Description
The study will assess mortality defined as death after admission to the hospital in patients with SpO2 <92%
Time Frame
Up to 21 days after enrollment
Title
Median Length of Stay
Description
The study will measure median length of stay in patients with COVID-19 that are hospitalized on subsequent return to the ED.
Time Frame
Up to 21 days after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Shah, DO
Organizational Affiliation
Swedish Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Swedish Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Home Pulse Oximeter Use in Patients With COVID-19

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