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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
Sponsor:
Information provided by (Responsible Party):
Kaushal Majmudar, Swedish Hospital

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.

Condition or disease Intervention/treatment Phase
Sars-CoV2 COVID-19 COVID Device: Home Pulse Oximetry Monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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%

  6. 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%

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Illinois
Swedish Hospital
Chicago, Illinois, United States, 60625
Sponsors and Collaborators
Swedish Hospital
Investigators
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Study Director: Sonia Shah, DO Swedish Hospital
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Responsible Party: Kaushal Majmudar, Physician, Swedish Hospital
ClinicalTrials.gov Identifier: NCT04373161    
Other Study ID Numbers: 2020032301
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Kaushal Majmudar, Swedish Hospital:
Oximetry
Oximeter
COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases