Home Pulse Oximeter Use in Patients With COVID-19
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04373161|
Recruitment Status : Completed
First Posted : May 4, 2020
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sars-CoV2 COVID-19 COVID||Device: Home Pulse Oximetry Monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||209 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Utilizing Home Pulse Oximetry for Patients With COVID-19 To Monitor Disease Progression|
|Actual Study Start Date :||March 20, 2020|
|Actual Primary Completion Date :||April 22, 2020|
|Actual Study Completion Date :||April 22, 2020|
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.
- Hospitalization in COVID-19 patients with low home SpO2 [ Time Frame: 7 days after enrollment ]The primary outcome is the relative risk of hospitalization in COVID-19 patients with resting home pulse oximeter SpO2 below 92%.
- Trend in resting home pulse oximetry readings [ Time Frame: 7 days after enrollment ]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% [ Time Frame: 7 days after enrollment ]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 [ Time Frame: 7 days after enrollment ]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 [ Time Frame: 7 days after enrollment ]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 [ Time Frame: Up to 21 days after enrollment ]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 [ Time Frame: Up to 21 days after enrollment ]The study will assess mortality defined as death after admission to the hospital in patients with SpO2 <92%
- Median Length of Stay [ Time Frame: Up to 21 days after enrollment ]The study will measure median length of stay in patients with COVID-19 that are hospitalized on subsequent return to the ED.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373161
|United States, Illinois|
|Chicago, Illinois, United States, 60625|
|Study Director:||Sonia Shah, DO||Swedish Hospital|