Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 7:10 PM
Study NCT ID:
NCT06033560
Status:
UNKNOWN
Last Update Posted:
2023-09-13
First Post:
2023-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related 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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}, {'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}, {'id': 'D058254', 'term': 'Stretchers'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D001513', 'term': 'Beds'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D014187', 'term': 'Transportation of Patients'}, {'id': 'D004632', 'term': 'Emergency Medical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2023-09-04', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients requiring invasive mechanical ventilation', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Mortality at day 30', 'timeFrame': '30 days'}, {'measure': 'ICU-free days', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Hypoxemic Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Coronavirus disease (COVID-19) can result in severe hypoxemic respiratory failure that ultimately may require invasive mechanical ventilation in the Intensive Care Unit (ICU). Although lifesaving, invasive mechanical ventilation is associated with high mortality, severe discomfort for patient, long-term sequelae, stress to loved-ones and high costs for society. During the ongoing pandemic high number of invasively ventilated COVID-19 patients overwhelmed ICU capacity.\n\nNon-invasive respiratory support, such as high flow nasal oxygen (HFNO) or non-invasive ventilation (NIV) have the potential to reduce the risk for invasive mechanical ventilation and in selected cases ICU admission. However, data from different studies are conflicting and studies performed in COVID-19 patients are of limited quality. Furthermore, identification of early predictors of HFNO/NIV treatment failure may prevent unnecessary delay of initiation of invasive ventilation, which may be associated with adverse clinical outcome. The development and validation of a prediction model, that incorporates readily available clinically data may prove pivotal to fine-tune non-invasive respiratory support.\n\nThe overall aim of the NORMO2 project is to investigate the role and risks of HFNO and NIV to improve outcome in hospitalized hypoxemic COVID-19 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '80 hospital sites across the United States', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sars-Cov-2 infection\n* hospital admission (emergency department, inpatient or ICU)\n* hypoxemic respiratory failure, defined as P/F ratio below or including 200\n\nExclusion Criteria:\n\n* hypercapnia (PCO2 \\> 45 mmHG in combination with acidemia (pH \\< 7.35))\n* pregnancy\n* do not resuscitate order'}, 'identificationModule': {'nctId': 'NCT06033560', 'acronym': 'NORMO2', 'briefTitle': 'The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in SARS-COV-2-related Hypoxemic Respiratory Failure', 'orgStudyIdInfo': {'id': 'RP-D0C3E4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Full analysis', 'description': 'All eligible patients.', 'interventionNames': ['Device: High flow nasal oxygen (HFNO, more than 15 L/min)']}, {'label': 'P/F ratio subgroups', 'description': 'Patients with a P/F ratio split in groups of \\<=100; 100-150; 150-200', 'interventionNames': ['Device: High flow nasal oxygen (HFNO, more than 15 L/min)']}, {'label': 'Respiratory rate subgroups', 'description': 'Patients with a respiratory rate split in groups of \\<=25; \\>25 breaths/min', 'interventionNames': ['Device: High flow nasal oxygen (HFNO, more than 15 L/min)']}, {'label': 'Body mass index (BMI) subgroups', 'description': 'Patients with BMI split in groups of \\<=25; 25-30; 30-35; \\>35 kg/m\\^2', 'interventionNames': ['Device: High flow nasal oxygen (HFNO, more than 15 L/min)']}, {'label': 'Immunocompromised subgroups', 'description': 'Immunocompromised patients due to medication or an underlined condition.', 'interventionNames': ['Device: High flow nasal oxygen (HFNO, more than 15 L/min)']}, {'label': 'Intensive care unit (ICU) subgroup', 'description': 'Only patients eligible within 24 hours of ICU admission.', 'interventionNames': ['Device: High flow nasal oxygen (HFNO, more than 15 L/min)']}], 'interventions': [{'name': 'High flow nasal oxygen (HFNO, more than 15 L/min)', 'type': 'DEVICE', 'otherNames': ['Non-invasive ventilation (NIV- Continuous positive airway pressure or bilevel positive airway pressure)', 'Conventional oxygen (COT, between 10 - 15 L/min)'], 'description': 'Non-invasive respiratory support strategy', 'armGroupLabels': ['Body mass index (BMI) subgroups', 'Full analysis', 'Immunocompromised subgroups', 'Intensive care unit (ICU) subgroup', 'P/F ratio subgroups', 'Respiratory rate subgroups']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data is accessible through the National COVID Cohort Collaborative website all relevant code for this project will be made available upon completion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof.dr. L.M.A. Heunks', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}