Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT04947358
Status:
UNKNOWN
Last Update Posted:
2021-07-01
First Post:
2019-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-23', 'studyFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital', 'timeFrame': '3 months', 'description': 'Define the proportion and causes of re-hospitalization and deaths within 3 months of discharge from hospital for patients admitted to the Emergency Department for acute dyspnea'}], 'secondaryOutcomes': [{'measure': 'Proportion and causes of re-hospitalization and deaths within 6 months of discharge from hospital', 'timeFrame': '6 months', 'description': 'Check theses parameters at 6 months, differentiating the cardiac causes from non-cardiac causes and the effect of home follow-up.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Longitudinal Observational Study With 6 Months Follow-up']}, 'descriptionModule': {'briefSummary': 'The purpose of the SIDI study is to follow, few months after discharge from the hospital, the patients admitted to the 3 emergency departments in Tunisia for acute dyspnea and to determine the proportion and the factors favoring rehospitalization and death.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted for unexpected respiratory difficulty', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients admitted for unexpected respiratory difficulty\n* Patient admitted to the emergency department\n* One of the following 3 criteria have to be present at admission to the ER:\n* O2 \\< or = 95%\n* Respiratory rate RR \\> or = 20\n* Suffocation sensation\n\nExclusion Criteria:\n\n* Patients \\<18 years old and\\> 85 years' old\n* Pregnancy\n* History of allergic asthma at early age\n* Diagnosis retained of pulmonary embolism\n* Patients with heart failure (HF) with left ventricular ejection fraction LVEF \\<40% are known beforehand or discovered at admission to ER\n* known Allergy for Polyamide; Polyester; Elastane; Silicone; Silver; Synthetic material Cardiorespiratory disorders which may be aggravated by the slight compression of the thorax Open wound on the skin, at the level of the trunk"}, 'identificationModule': {'nctId': 'NCT04947358', 'acronym': 'SIDI', 'briefTitle': 'Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia', 'organization': {'class': 'INDUSTRY', 'fullName': 'S Form Pharma'}, 'officialTitle': 'Longitudinal Observational Study for mIddle Term Follow-up Patients Admitted for Acute Dyspnea in TunIsia', 'orgStudyIdInfo': {'id': 'AD201801'}}, 'contactsLocationsModule': {'locations': [{'city': 'Monastir', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Semir Nouira', 'role': 'CONTACT', 'email': 'semir.nouira@rns.tn', 'phone': '+21673106085'}, {'name': 'Riadh Boukef', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Houda Ben Soltane', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ER, Fattouma Bourguiba Hospital', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'centralContacts': [{'name': 'Eric Halioua, CEO', 'role': 'CONTACT', 'email': 'halioua_eric@yahoo.fr', 'phone': '+32474057866'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S Form Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}