Home Pulse Oximeter Use in Patients With COVID-19

NCT ID: NCT04373161

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-04-22

Brief Summary

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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

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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.

Conditions

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Sars-CoV2 COVID-19 COVID

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Home Pulse Oximetry Monitoring

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kaushal Majmudar

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sonia Shah, DO

Role: STUDY_DIRECTOR

Swedish Hospital

Locations

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Swedish Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2020032301

Identifier Type: -

Identifier Source: org_study_id

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