Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-01 @ 6:29 PM
Study NCT ID:
NCT04373161
Status:
COMPLETED
Last Update Posted:
2020-05-06
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Pulse Oximeter Use in Patients With COVID-19
Sponsor:
Swedish Hospital
Organization:
Study Overview
Official Title:
Utilizing Home Pulse Oximetry for Patients With COVID-19 To Monitor Disease Progression
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: