Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-01 @ 12:26 PM
Study NCT ID:
NCT03557320
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2016-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Environmental Factor and Onset of Spontaneous Pneumothorax
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3090}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-24', 'studyFirstSubmitDate': '2016-09-05', 'studyFirstSubmitQcDate': '2018-06-04', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate odds ratio for the association between meteorological data and onset of PSP.', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['environment', 'pressure', 'temperature', 'case-crossover'], 'conditions': ['Spontaneous Pneumothorax']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the association between spontaneous pneumothorax onset and weather parameters.', 'detailedDescription': "The aim of this study is to analyse the relation between onset of the PSP and exposure to environmental factors such as atmospheric pressure.\n\nA case-crossover epidemiological study will be conducted in 14 French hospitals. SP recorded from 2009 to 2013 will be exhaustively included. Demographic and clinical characteristics will be collected. For each incident case of SP, the period of occurrence of the event (case period) will be compared to several other periods temporally distant from the case period (control periods prior to and after the event). Exposure will be assessed using meteorological stations localized in the vicinity of each patient's home. A potential threshold effect and/or time lag effect between exposure and admission for SP will be explored.\n\nThe results of this study will help to identify the meteorological factors associated with the occurrence of SP, and to deepen our knowledge of the pathophysiological mechanisms of SP especially the influence of meteorological factors on bleb rupture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were recruited in the emergency departments (ED) of fourteen French hospitals that are members of the EXPRED Network (EXPRED Study) (Desmettre et al. 2011) where emergency admission management software was available.\n\nA search was performed of ED admissions databases to identify all patients with a primary diagnosis of pneumothorax (International Classification of Diseases (ICD) 10 code = J93) admitted between June 1, 2009 and May 31, 2013).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18 years\n* first episode of primary spontaneous pneumothorax\n\nExclusion Criteria:\n\n* Patients with traumatic\n* Patients with secondary pneumothorax\n* Patients with recurrent pneumothorax and patients with short-term readmissions (recurrence was defined as a new ED admission for the same diagnosis more than 14 days after the first admission).'}, 'identificationModule': {'nctId': 'NCT03557320', 'acronym': 'EXPPO', 'briefTitle': 'Environmental Factor and Onset of Spontaneous Pneumothorax', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Impact of Meteorological Conditions on the Onset of First Episod of Spontaneous Pneumothorax : a French Multicenter Case-crosserover Study About 945 Subjects in 14 Centers', 'orgStudyIdInfo': {'id': 'API/2012/29'}}, 'contactsLocationsModule': {'locations': [{'zip': '49100', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '90016', 'city': 'Belfort', 'country': 'France', 'facility': 'Centre Hospitalier de Belfort', 'geoPoint': {'lat': 47.64218, 'lon': 6.85385}}, {'zip': '62320', 'city': 'Boulogne-sur-Mer', 'country': 'France', 'facility': 'CH Boulogne sur Mer', 'geoPoint': {'lat': 50.72485, 'lon': 1.61373}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21033', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '62460', 'city': 'Divion', 'country': 'France', 'facility': 'Polyclinique de DIVION', 'geoPoint': {'lat': 50.47169, 'lon': 2.50546}}, {'zip': '62110', 'city': 'Hénin-Beaumont', 'country': 'France', 'facility': 'Clinique de HENIN BEAUMONT', 'geoPoint': {'lat': 50.41359, 'lon': 2.96485}}, {'zip': '59160', 'city': 'Lomme', 'country': 'France', 'facility': 'CH Lomme', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}, {'zip': '68051', 'city': 'Mulhouse', 'country': 'France', 'facility': 'CH Mulhouse', 'geoPoint': {'lat': 47.75205, 'lon': 7.32866}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '70000', 'city': 'Vesoul', 'country': 'France', 'facility': 'Centre Hospitalier de Vesoul', 'geoPoint': {'lat': 47.62604, 'lon': 6.14251}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, {'name': 'Hopital Nord Franche-Comte', 'class': 'OTHER'}, {'name': 'Groupe Hospitalier de la Region de Mulhouse et Sud Alsace', 'class': 'OTHER'}, {'name': 'Centre Hospitalier de la Haute Saone', 'class': 'UNKNOWN'}, {'name': 'CHU de Reims', 'class': 'OTHER'}, {'name': 'Centre Hospitalier de Bethune', 'class': 'NETWORK'}, {'name': 'Centre Hospitalier Saint Philibert Lomme', 'class': 'UNKNOWN'}, {'name': 'Centre Hospitalier de Roubaix', 'class': 'OTHER'}, {'name': 'Boulogne sur Mer Hospital Center', 'class': 'OTHER'}, {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Angers', 'class': 'UNKNOWN'}, {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}