Home Pulse Oximeter Use in Patients With COVID-19
Utilizing Home Pulse Oximetry for Patients With COVID-19 To Monitor Disease Progression
1 other identifier
interventional
209
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2020
CompletedFirst Submitted
Initial submission to the registry
April 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedMay 6, 2020
May 1, 2020
1 month
April 30, 2020
May 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalization in COVID-19 patients with low home SpO2
The primary outcome is the relative risk of hospitalization in COVID-19 patients with resting home pulse oximeter SpO2 below 92%.
7 days after enrollment
Secondary Outcomes (7)
Trend in resting home pulse oximetry readings
7 days after enrollment
Timing of SpO2 <92%
7 days after enrollment
Home pulse oximeter use effect on subsequent ED visits
7 days after enrollment
Reason for return to the Emergency Department
7 days after enrollment
Hospitalization outcome - morbidity
Up to 21 days after enrollment
- +2 more secondary outcomes
Study Arms (1)
Suspected COVID-19 patients being discharged to home
EXPERIMENTALPatients will be given a portable, fingertip pulse oximeter to take home. Patients will monitor their resting home oxygen saturation three times per day.
Interventions
Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen \<92% or for worsening symptoms.
Eligibility Criteria
You may qualify if:
- Patients with suspected COVID-19 as defined by the World Health Organization
- Age \> 18
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swedish Hospitallead
Study Sites (1)
Swedish Hospital
Chicago, Illinois, 60625, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sonia Shah, DO
Swedish Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
April 30, 2020
First Posted
May 4, 2020
Study Start
March 20, 2020
Primary Completion
April 22, 2020
Study Completion
April 22, 2020
Last Updated
May 6, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share