Nctid:
NCT06235359
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000004653", "term"=>"Empyema"}], "ancestors"=>[{"id"=>"D000013492", "term"=>"Suppuration"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000007249", "term"=>"Inflammation"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M7819", "name"=>"Empyema", "asFound"=>"Empyema", "relevance"=>"HIGH"}, {"id"=>"M16273", "name"=>"Suppuration", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2023-10-11", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-11", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To find best way to drain the pus in the pleural space", "timeFrame"=>"baseline", "description"=>"To find best way to drain the pus in the pleural space"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Empyema"]}, "referencesModule"=>{"references"=>[{"pmid"=>"2400254", "type"=>"BACKGROUND", "citation"=>"Ali I, Unruh H. Management of empyema thoracis. Ann Thorac Surg. 1990 Sep;50(3):355-9. doi: 10.1016/0003-4975(90)90474-k."}]}, "descriptionModule"=>{"briefSummary"=>"Is intercostal tube enough in management of empyema ?", "detailedDescription"=>"Empyema refers to presence of pus in the pleural space -Causes Primary: bacterial Pneumonia (staph aureus, strept pneumonia , H.influenza) , TB\n\nSecondry :\n\nPostTraumati postoperative :open heart , esophageal, mediastinum , lung rupture of lung absess\n\n-pathophysiology and stages During an inflammatory process such as pneumonia, there is an increase in fluid production in the pleural cavity known as the exudate stage. As the disease progresses microorganisms, usually bacteria, can colonize the fluid and generated an empyema. This fluid is characterized by elevated lactate dehydrogenase, proteins, neutrophils, and dead cells. Macroscopically is a thick opaque fluid found in the fibrinopurulent stage. After the resolution of the infection and as a consequence of the inflammation, there is a process of fibrosis that can lead to restriction of the lung parenchyma which is stage of chronic organization"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* patients admitted to Assuit university Hospital and diagnosed with empyema\n\nExclusion Criteria:\n\n* Patient diagnosed with Post-operative empyema\n* Patient diagnosed with post traumatic empyema\n* Patient diagnosed with Bronchopleural fistula\n* Patient diagnosed with TB"}, "identificationModule"=>{"nctId"=>"NCT06235359", "briefTitle"=>"Is Intercostal Tube Enough in Management of Empyema", "organization"=>{"class"=>"OTHER", "fullName"=>"Assiut University"}, "officialTitle"=>"Is Intercostal Tube Enough in Management of Empyema", "orgStudyIdInfo"=>{"id"=>"empyema"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"OTHER", "label"=>"intercostal tube", "description"=>"A chest tube is a hollow, flexible tube placed into the chest. It acts as a drain.\n\nChest tubes drain blood, fluid, or air from around your lungs, heart, or esophagus.\n\nThe tube around your lung is placed between your ribs and into the space between the inner lining and the outer lining of your chest cavity. This is called the pleural space. It allows your lungs to fully expand.", "interventionNames"=>["Device: intercostal tube"]}], "interventions"=>[{"name"=>"intercostal tube", "type"=>"DEVICE", "description"=>"A chest tube is a hollow, flexible tube placed into the chest. It acts as a drain.\n\nChest tubes drain blood, fluid, or air from around your lungs, heart, or esophagus.\n\nThe tube around your lung is placed between your ribs and into the space between the inner lining and the outer lining of your chest cavity. This is called the pleural space. It allows your lungs to fully expand.", "armGroupLabels"=>["intercostal tube"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Islam abdelfatah, resident", "role"=>"CONTACT", "email"=>"Islam.abdelfatah.097@gmail.com", "phone"=>"01024984239"}, {"name"=>"Mahmoud khairy, professor", "role"=>"CONTACT", "email"=>"Mahkhairy02@yahoo.com", "phone"=>"01098935293"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Assiut University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"physician", "investigatorFullName"=>"Islam Abdelfatah mahmoud", "investigatorAffiliation"=>"Assiut University"}}}}
