Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 4:01 PM
Study NCT ID:
NCT04565106
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2020-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D000860', 'term': 'Hypoxia'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time in SpO2 target', 'timeFrame': '1 week', 'description': 'Time in SpO2 target of 92-96 %'}], 'secondaryOutcomes': [{'measure': 'Time with SpO2 not more than 2 % outside target', 'timeFrame': '1 week', 'description': 'Time with SpO2 not more than 2 % outside target'}, {'measure': 'Time with SpO2 more than 2 % outside target', 'timeFrame': '1 week', 'description': 'Time with SpO2 more than 2 % outside target'}, {'measure': 'Time with SpO2 < 85 %', 'timeFrame': '1 week', 'description': 'Time with SpO2 \\< 85 %'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['O2matic', 'Closed-loop'], 'conditions': ['Covid19', 'Hypoxemic Respiratory Failure', 'Hypoxemia']}, 'descriptionModule': {'briefSummary': 'Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.', 'detailedDescription': 'Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.\n\nPatients were prospectively enrolled in an observational study on a medical ward dedicated to patients with COVID-19. Closed-loop controlled oxygen was delivered by O2matic® which can deliver 0-15 liters/min and adjusts flow every second based on 15 seconds averaging of SpO2 measured by pulse oximetry. Lung function parameters were measured at admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted with COVID-19 pneumonitis and in need of oxygen supplementation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years\n* Positive COVID-19 PCR analysis in pharyngeal swab or in tracheal secretion\n* Need oxygen supply to maintain SpO2 ≥ 92 %\n* Able to comply with continuous measurement of SpO2 by pulse oximetry.\n\nExclusion Criteria:\n\n* Need of oxygen supply \\> 10 liters/min at admission'}, 'identificationModule': {'nctId': 'NCT04565106', 'acronym': 'O2matic-COVI', 'briefTitle': 'Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Automatic Oxygen Titration With O2matic® to Patients Admitted With COVID-19 and Hypoxemic Respiratory Failure', 'orgStudyIdInfo': {'id': 'O2matic-COVID'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Closed-loop control of oxygen supplementation by O2matic', 'type': 'DEVICE', 'description': 'Closed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 %'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3550', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Ove Andersen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hvidovre University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innovation Fund Denmark', 'class': 'INDIV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Ejvind Frausing Hansen', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}