Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-01 @ 6:29 PM
Study NCT ID:
NCT04373161
Status:
COMPLETED
Last Update Posted:
2020-05-06
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home Pulse Oximeter Use in Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization in COVID-19 patients with low home SpO2', 'timeFrame': '7 days after enrollment', 'description': 'The primary outcome is the relative risk of hospitalization in COVID-19 patients with resting home pulse oximeter SpO2 below 92%.'}], 'secondaryOutcomes': [{'measure': 'Trend in resting home pulse oximetry readings', 'timeFrame': '7 days after enrollment', 'description': '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'}, {'measure': 'Timing of SpO2 <92%', 'timeFrame': '7 days after enrollment', 'description': '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.'}, {'measure': 'Home pulse oximeter use effect on subsequent ED visits', 'timeFrame': '7 days after enrollment', 'description': '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'}, {'measure': 'Reason for return to the Emergency Department', 'timeFrame': '7 days after enrollment', 'description': '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'}, {'measure': 'Hospitalization outcome - morbidity', 'timeFrame': 'Up to 21 days after enrollment', 'description': '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%'}, {'measure': 'Hospitalization outcome - mortality', 'timeFrame': 'Up to 21 days after enrollment', 'description': 'The study will assess mortality defined as death after admission to the hospital in patients with SpO2 \\<92%'}, {'measure': 'Median Length of Stay', 'timeFrame': 'Up to 21 days after enrollment', 'description': 'The study will measure median length of stay in patients with COVID-19 that are hospitalized on subsequent return to the ED.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Oximetry', 'Oximeter', 'COVID-19'], 'conditions': ['Sars-CoV2', 'COVID-19', 'COVID']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected COVID-19 as defined by the World Health Organization\n* Age \\> 18\n\nExclusion Criteria:\n\n* Pregnancy\n* Prisoners\n* Lack of decision making capacity or cannot provide consent\n* Patients being admitted to the hospital\n* Patients on home oxygen\n* Patients being discharged to a skilled nursing facility'}, 'identificationModule': {'nctId': 'NCT04373161', 'briefTitle': 'Home Pulse Oximeter Use in Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Swedish Hospital'}, 'officialTitle': 'Utilizing Home Pulse Oximetry for Patients With COVID-19 To Monitor Disease Progression', 'orgStudyIdInfo': {'id': '2020032301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suspected COVID-19 patients being discharged to home', 'description': 'Patients will be given a portable, fingertip pulse oximeter to take home. Patients will monitor their resting home oxygen saturation three times per day.', 'interventionNames': ['Device: Home Pulse Oximetry Monitoring']}], 'interventions': [{'name': 'Home Pulse Oximetry Monitoring', 'type': 'DEVICE', 'description': 'Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen \\<92% or for worsening symptoms.', 'armGroupLabels': ['Suspected COVID-19 patients being discharged to home']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60625', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Swedish Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Sonia Shah, DO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Swedish Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swedish Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Kaushal Majmudar', 'investigatorAffiliation': 'Swedish Hospital'}}}}