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Completed

NCT Number: NCT04373161

Home Pulse Oximeter Use in Patients With COVID-19

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.

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Key information

Conditions

Sars-CoV2 COVID COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swedish Hospital

Chicago, Illinois, 60625, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Pulse Oximetry Monitoring

Device

Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen <92% or for worsening symptoms.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Swedish Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 4, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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