Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT04649658
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2020-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support
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': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endotracheal intubation', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28 days'}, {'measure': 'Tracheostomy', 'timeFrame': '28 days'}, {'measure': 'Length of Respiratory Intensive Care Unit stay', 'timeFrame': '60 days'}, {'measure': 'Length of Hospital stay', 'timeFrame': '60 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spontaneous breathing', 'Awake pronation', 'COVID-19', 'Respiratory failure'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Pronation seems feasible and effective in improving blood oxygenation in patients with COVID-19 pneumonia. Data are lacking on the effects of pronation on clinical outcome in this subset of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients aged ≥18 and \\< 80 years old admitted to the two respiratory intensive care units for severe and critical COVID-19 pneumonia between March 1st, 2020 and June 1st, 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria\n\n* patients aged ≥18 and \\< 80 years old\n* acute respiratory failure\n\nExclusion Criteria:\n\n* endotracheal intubation performed within the first 24 hours from admission,\n* ceiling of escalation of intensive care\n* do not intubate order as expressed by patient willing or upon clinical judgement\n* missing core data at medical record analysis (clinical features at baseline, pronation information, type and time of ventilatory support required, mortality, need for tracheostomy, length of respiratory intensive care unit and hospital stay).'}, 'identificationModule': {'nctId': 'NCT04649658', 'acronym': 'PRINCESS', 'briefTitle': 'Pronation in COVID-19 Patients Undergoing Non Invasive Respiratory Support', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Awake Prone Position in Critical and Severe COVID-19 Patients Undergoing Noninvasive Respiratory Support: a Retrospective Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'UModenaReggio10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prone position', 'description': 'Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to prone position', 'interventionNames': ['Behavioral: Prone position']}, {'label': 'Standard care', 'description': 'Severe and critical COVID-19 patients undergoing non invasive respiratory support subjected to standard care'}], 'interventions': [{'name': 'Prone position', 'type': 'BEHAVIORAL', 'description': 'Prone position maintained at least 3 hours/day', 'armGroupLabels': ['Prone position']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Modena', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Policlinico di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Roberto Tonelli', 'investigatorAffiliation': 'University of Modena and Reggio Emilia'}}}}