Nctid:
NCT06611683
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000016638", "term"=>"Critical Illness"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M27137", "name"=>"Respiratory Aspiration", "relevance"=>"LOW"}, {"id"=>"M19010", "name"=>"Critical Illness", "asFound"=>"Critically Ill", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2019-07-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2020-12-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-10-01", "studyFirstSubmitDate"=>"2024-09-22", "studyFirstSubmitQcDate"=>"2024-09-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2020-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of days until liberation from mechanical ventilation", "timeFrame"=>"Three weeks", "description"=>"A record of the number of days until liberation from mechanical ventilation."}], "secondaryOutcomes"=>[{"measure"=>"Maximum inspiratory pressure", "timeFrame"=>"Three weeks", "description"=>"Maximum inspiratory pressure was measured by having each subject exert maximum inspiratory force against a pressure gauge."}, {"measure"=>"Maximum expiratory pressure", "timeFrame"=>"Three weeks", "description"=>"Maximum expiratory pressure was measured by having each subject exert maximum expiratory force against a pressure gauge."}, {"measure"=>"Peak expiratory flow", "timeFrame"=>"Three weeks", "description"=>"The peak expiratory flow was measured using a respiratory mechanics monitor during three forceful expirations."}, {"measure"=>"Peak inspiratory flow", "timeFrame"=>"Three weeks", "description"=>"The peak inspiratory flow was measured using a respiratory mechanics monitor during three forceful expirations."}, {"measure"=>"Rapid Shallow breathing index", "timeFrame"=>"Three weeks", "description"=>"The RSBI was calculated by dividing the respiratory rate by the tidal volume"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["sub-acute critical ill", "mechanical ventilation", "respiratory muscle training", "respiratory muscle strength", "rapid shallow breathing index"], "conditions"=>["Critically Ill, Subacute Adult Patients", "Mechanically Ventilation"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to learn if inspiratory muscle training facilite the liberation of mechanical ventilation. The main questions it aims to answer are:\n\nDoes inspiratory muscle training facilitate weaning from mechanical ventilation and enhance muscle strength in critically ill, subacute adult patients?\n\nThe main questions it aims to answer are:\n\nDoes pulmonary rehabilitation facilitate wwaning form mechanical patients? Does the intervention improve respiratory muscle strength and respiratory patterns?\n\nParticipants received:\n\nInspriatory muscle training twice daily for three consecutive weeks or until the subject no longer required ventilator support.", "detailedDescription"=>"Patients on mechanical ventilation often experience rapid diaphragm atrophy on the second day, resulting in muscle fiber changes, respiratory muscle weakness. Clinical studies have explored enhancing diaphragm and respiratory muscle strength and endurance through inspiratory muscle, expiratory muscle, and combined respiratory muscle training. This study was to determine if inspiratory muscle training significantly facilitates liberation from mechanical ventilation and improves muscle strength when compared to without IMT among subacute critically ill adult patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* requiring invasive mechanical ventilation for 2 days in an ICU\n\nExclusion Criteria:\n\n* hemodynamic instability (heart rate 120 beats/min, unstable blood pressure, vasopressor infusion)\n* inadequate oxygenation (PEEP 8 cmH2O, FiO2 50%)\n* body temperature 38.5°C\n* sepsis\n* use of sedative infusion\n* steroid administration\n* home ventilator use before ICU admission"}, "identificationModule"=>{"nctId"=>"NCT06611683", "briefTitle"=>"Effect of Inspiratory Muscle Training on Ventilated Patients in an Intensive Care Unit", "organization"=>{"class"=>"OTHER", "fullName"=>"Chang Gung University"}, "officialTitle"=>"Effect of Inspiratory Muscle Training on Ventilated Patients in an Intensive Care Unit", "orgStudyIdInfo"=>{"id"=>"KAFGHIRB107-027"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Inspiratory Muscle Training", "description"=>"Subjects received inspiratory muscle training twice daily over five consecutive days, followed by a two-day rest period. This regimen was continued for three consecutive weeks or until the subject no longer required ventilator support.", "interventionNames"=>["Procedure: Inspiratory muscle training"]}, {"type"=>"SHAM_COMPARATOR", "label"=>"Non-inspiratory muscle training", "description"=>"Subjects received routine care.", "interventionNames"=>["Procedure: Routine care"]}], "interventions"=>[{"name"=>"Inspiratory muscle training", "type"=>"PROCEDURE", "description"=>"A threshold inspiratory muscule device used a starting resistance set at 30% maximum inspiratory pressure, connecting to subject artificial airway. The subjects were then instructed to perform fast and forceful inspirations against added inspiratory resistance. The inspiratory muscle training was conducted twice daily over five consecutive days, followed by a two-day rest period. This regimen continued for three consecutive weeks or until the subject no longer required ventilator support.", "armGroupLabels"=>["Inspiratory Muscle Training"]}, {"name"=>"Routine care", "type"=>"PROCEDURE", "description"=>"Subjects received routine care without intervention.", "armGroupLabels"=>["Non-inspiratory muscle training"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Kaohsiung", "country"=>"Taiwan", "facility"=>"Zuoying Armed Forces General Hospital", "geoPoint"=>{"lat"=>22.61626, "lon"=>120.31333}}], "overallOfficials"=>[{"name"=>"Shu-Jane Wang, MS", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Zuoying Armed Forces General Hospital"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL", "SAP"], "timeFrame"=>"The data will become available 3 three years after the registration", "ipdSharing"=>"YES", "description"=>"The data is available upon request from the principal investigator.", "accessCriteria"=>"The data is available upon request from the principal investigator."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Chang Gung University", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Zuoying Armed Forces General Hospital", "class"=>"UNKNOWN"}, {"name"=>"Kaohsiung Chang Gung Memorial Hospital,Taiwan", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Hui-Ling Lin", "investigatorAffiliation"=>"Chang Gung University"}}}}
