Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-29 @ 6:33 AM
Study NCT ID:
NCT04341766
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2020-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid (Coronavirus Disease) 19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-16', 'studyFirstSubmitDate': '2020-04-01', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristics of pulmonary ultrasound for Covid-19 patients', 'timeFrame': 'Day one', 'description': 'description of ultrasound abnormalities for Covid-19 patients'}], 'secondaryOutcomes': [{'measure': 'Characteristics of pulmonary ultrasound for Covid-19 patients', 'timeFrame': 'Day 3', 'description': 'description of ultrasound abnormalities for Covid-19 patients'}, {'measure': 'Characteristics of pulmonary ultrasound for Covid-19 patients', 'timeFrame': 'Day 14', 'description': 'description of ultrasound abnormalities for Covid-19 patients'}, {'measure': 'Charateristics of pulmonary CT-scan for Covid-19 patients', 'timeFrame': 'Day 1', 'description': 'description of CT-scan abnormalities for Covid-19 patients'}, {'measure': 'Charateristics of pulmonary CT-scan for Covid-19 patients', 'timeFrame': 'Day 3', 'description': 'description of CT-scan abnormalities for Covid-19 patients'}, {'measure': 'Charateristics of pulmonary CT-scan for Covid-19 patients', 'timeFrame': 'Day 14', 'description': 'description of CT-scan abnormalities for Covid-19 patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia, Viral', 'COVID-19']}, 'descriptionModule': {'briefSummary': 'Clinical thoracic ultrasound plays an important role in the exploration, diagnosis and follow-up of thoracic pathologies.\n\nThe COVID (Coronavirus Disease) epidemic is leading to a large influx of patients in the emergency department with respiratory disorders. The rapid diagnosis of respiratory disorders in infected patients is important for further management.\n\nChest ultrasound has already demonstrated its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray.\n\nHowever, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.', 'detailedDescription': "Chest ultrasound has already shown its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray.\n\nHowever, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.\n\nPeng reported data from 20 patients and compared them to chest CT. The abnormalities are a thickening of the pleuropneumonia line, an interstitial syndrome with B lines, corresponding to frosted glass opacities, confluent B lines (snowstorm appearance) corresponding to interstitial infiltrate, sub-pleural alveolar opacities corresponding to sub-pleural condensations, more frank alveolar images corresponding to alveolar opacities. A multifocal aspect was associated with involvement of more than 2 lobes. However, the frequency of these abnormalities as well as the sensitivity of the echo are not detailed in this article.\n\nAnother Italian article describes a clinical case of COVID-19 pneumonia with sub-pleural involvement and irregularity of the pleuro-pulmonary line.\n\nClinical thoracic ultrasound has a major potential interest during the COVID epidemic: available at the patient's bedside, avoiding the need to move around, feasible for the physician during his visit, easy to clean especially if ultraportable devices are used, fast and not exposing the staff any more than the usual clinical examination.\n\nIn order to determine whether this technique is useful in the management of infected patients or patients suspected of COVID-19 infection with respiratory signs, we propose a descriptive prospective study evaluating the ultrasound semiology of COVID-19 pneumonia and the interest of ultrasound in the evolutionary follow-up of these patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient admitted to hospital with proven COVID-19 infection with respiratory signs and who need an hospitalization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to hospital with proven COVID-19 infection with respiratory signs warranting a chest CT scan\n\nExclusion Criteria:\n\n* Patient not agreeing to have his or her data collected for the study\n* Unconscious patient'}, 'identificationModule': {'nctId': 'NCT04341766', 'briefTitle': 'Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid (Coronavirus Disease) 19', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': 'Prospective Descriptive Study on the Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid19', 'orgStudyIdInfo': {'id': 'COVID-ECHO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient hospitalised with COVID-19 infection', 'description': 'Patients admitted to hospital with proven COVID-19 infection with respiratory signs warranting a chest CT scan', 'interventionNames': ['Other: No special intervention']}], 'interventions': [{'name': 'No special intervention', 'type': 'OTHER', 'description': 'No special intervention : Ultrasound data will be collected', 'armGroupLabels': ['Patient hospitalised with COVID-19 infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '64109', 'city': 'Bayonne', 'country': 'France', 'facility': 'CH de la Côte Basque', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '92104', 'city': 'Boulogne-Billancourt', 'country': 'France', 'facility': 'CHU Ambroise Paré', 'geoPoint': {'lat': 48.83545, 'lon': 2.24128}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '73000', 'city': 'Chambéry', 'country': 'France', 'facility': 'CHG de Chambery', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '94000', 'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Créteil', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '87000', 'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'APHM - Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '54035', 'city': 'Nancy', 'country': 'France', 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '45100', 'city': 'Orléans', 'country': 'France', 'facility': 'CHR Orléans', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '02321', 'city': 'Saint-Quentin', 'country': 'France', 'facility': 'CH Saint-Quentin', 'geoPoint': {'lat': 49.84889, 'lon': 3.28757}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Larrey - Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}