Nctid:
NCT06612242
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D020275", "term"=>"Guillain-Barre Syndrome"}, {"id"=>"D013577", "term"=>"Syndrome"}], "ancestors"=>[{"id"=>"D004194", "term"=>"Disease"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D011129", "term"=>"Polyradiculoneuropathy"}, {"id"=>"D020274", "term"=>"Autoimmune Diseases of the Nervous System"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D003711", "term"=>"Demyelinating Diseases"}, {"id"=>"D011115", "term"=>"Polyneuropathies"}, {"id"=>"D010523", "term"=>"Peripheral Nervous System Diseases"}, {"id"=>"D009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D000094025", "term"=>"Post-Infectious Disorders"}, {"id"=>"D002908", "term"=>"Chronic Disease"}, {"id"=>"D020969", "term"=>"Disease Attributes"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M22095", "name"=>"Guillain-Barre Syndrome", "asFound"=>"Guillain-Barre Syndrome", "relevance"=>"HIGH"}, {"id"=>"M14013", "name"=>"Polyradiculoneuropathy", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M22094", "name"=>"Autoimmune Diseases of the Nervous System", "relevance"=>"LOW"}, {"id"=>"M6909", "name"=>"Demyelinating Diseases", "relevance"=>"LOW"}, {"id"=>"M13999", "name"=>"Polyneuropathies", "relevance"=>"LOW"}, {"id"=>"M13432", "name"=>"Peripheral Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3014", "name"=>"Post-Infectious Disorders", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T2640", "name"=>"Guillain-Barre Syndrome", "asFound"=>"Guillain-Barre Syndrome", "relevance"=>"HIGH"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"OTHER", "observationalModel"=>"OTHER"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"ventilation days", "timeFrame"=>"1 year from intubation", "description"=>"number of ventilation days"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Guillain Barre Syndrome", "Mechanical Ventilation"]}, "descriptionModule"=>{"briefSummary"=>"Tracheostomy is one of the most common procedures in the intensive care unit in patients who need prolonged invasive mechanical ventilation. There is controversy in the literature regarding the ideal timing for performing tracheostomy in critically ill patients. Early tracheostomy may be associated with a decrease in ventilation days and hospitalization. We would like to investigate whether in ventilated patients with Guillain Barre syndrome, early tracheostomy will be associated with decreased ventilation days, decreased mortality and shorter hospital and ICU length of stay."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"All patients aged 18--99 who were admitted to the general intensive care unit from January 2012 to September 2024 with a diagnosis of Guillain-Barre syndrome who required mechanical ventilation and underwent tracheostomy during ICU stay", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria: All patients aged 18--99 who were admitted to the general intensive care unit from January 2012 to September 2024 with a diagnosis of Guillain-Barre syndrome who required mechanical ventilation and underwent tracheostomy during ICU stay.\n\n-\n\nExclusion Criteria: Missing recoreded data\n\n-"}, "identificationModule"=>{"nctId"=>"NCT06612242", "briefTitle"=>"Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome", "organization"=>{"class"=>"OTHER", "fullName"=>"Meir Medical Center"}, "officialTitle"=>"Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome: Comparison of Clinical Outcomes- a Retrospective Study", "orgStudyIdInfo"=>{"id"=>"0206-24-MMC"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Early tracheostomy", "description"=>"Patients with Guillain Barre who underwent early tracheostomy", "interventionNames"=>["Procedure: early tracheostomy (less than 7 days from intubation)"]}, {"label"=>"Late tracheostomy", "description"=>"Patients with Guillain Barre who underwent late tracheostomy", "interventionNames"=>["Procedure: Late tracheostomy (more than 7 days from intubation)"]}], "interventions"=>[{"name"=>"early tracheostomy (less than 7 days from intubation)", "type"=>"PROCEDURE", "description"=>"Early tracheostomy (less than 7 days from ventilation) in mechanically ventilated patients with Guiilain-Barre syndrome", "armGroupLabels"=>["Early tracheostomy"]}, {"name"=>"Late tracheostomy (more than 7 days from intubation)", "type"=>"PROCEDURE", "description"=>"Late tracheostomy (more than 7 days from ventilation) in mechanically ventilated patients with Guiilain-Barre syndrome", "armGroupLabels"=>["Late tracheostomy"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Dr Sara Dichtwald, MD", "role"=>"CONTACT", "email"=>"sara.dichtwald@clalit.org.il", "phone"=>"972-9-7472133", "phoneExt"=>"1"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Meir Medical Center", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Dr", "investigatorFullName"=>"sara dichtwald", "investigatorAffiliation"=>"Meir Medical Center"}}}}
