Nctid:
NCT06222333
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000050723", "term"=>"Fractures, Bone"}, {"id"=>"D000012253", "term"=>"Rib Fractures"}], "ancestors"=>[{"id"=>"D000014947", "term"=>"Wounds and Injuries"}, {"id"=>"D000013898", "term"=>"Thoracic Injuries"}], "browseLeaves"=>[{"id"=>"M15082", "name"=>"Rib Fractures", "asFound"=>"Rib Fractures", "relevance"=>"HIGH"}, {"id"=>"M26370", "name"=>"Fractures, Bone", "asFound"=>"Fracture", "relevance"=>"HIGH"}, {"id"=>"M27137", "name"=>"Respiratory Aspiration", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M16657", "name"=>"Thoracic Injuries", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SUPPORTIVE_CARE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>62}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-04-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-04-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-15", "studyFirstSubmitDate"=>"2024-01-03", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"FEV1, FVC, FEV1/FVC results on day 7", "timeFrame"=>"7 days", "description"=>"FEV1, FVC, FEV1/FVC"}], "secondaryOutcomes"=>[{"measure"=>"Number of Participants with Pneumonia", "timeFrame"=>"7 days", "description"=>"Clinical and radiological diagnosis of pneumonia"}, {"measure"=>"FEV1, FVC, FEV1/FVC results on day 2", "timeFrame"=>"2 days", "description"=>"FEV1, FVC, FEV1/FVC"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Rib Fractures", "Spirometry"]}, "descriptionModule"=>{"briefSummary"=>"Respiratory physiotherapy is routinely performed after thoracic surgery operations to increase lung expansion and prevent pulmonary complications such as atelectasis and pneumonia. It is a controversial issue whether respiratory physiotherapy reduces pulmonary complications in rib fractures. In our study, patients with rib fractures will be divided into two groups. In the control group, standard treatment consisting of routine analgesic treatments will be applied. In the other group, respiratory physiotherapy will be applied with triflu for 8 hours a day. At the end of the study, pulmonary complications in both groups will be compared.", "detailedDescription"=>"Patients between the ages of 18 and 100 who will apply to our hospital due to rib fractures between April 2024 and April 2025 will be evaluated. Patients who meet the inclusion criteria will be included in the study. Patients will be divided into two groups using randomization blocks. Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen. In the other group of patients, in addition to conservative treatment, triflow breathing exercise will be applied for 8 hours a day. Respiratory function test pain scores and pulmonary complications of patients in the two groups will be compared statistically."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"100 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Isolated thoracic injury within 24 hours\n* Age between 18-100\n\nExclusion Criteria:\n\n* Pneumothorax and hemothorax requiring intervention at admission\n* Injury severity index \\>16\n* COPD, Atshma\n* Extrathoracic trauma"}, "identificationModule"=>{"nctId"=>"NCT06222333", "briefTitle"=>"Breathing Exercise for Rib Fracture", "organization"=>{"class"=>"OTHER", "fullName"=>"Kastamonu University"}, "officialTitle"=>"Can Breathing Exercise Reduce Pulmonary Complications in Rib Fractures: Randomized Prospective Study", "orgStudyIdInfo"=>{"id"=>"KastamonuU1"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Respiratory physiotherapy group", "description"=>"In this group of patients, in addition to routine analgesic treatment, triflow use and deep breathing training would be given by the physiotherapist. Patients in this group will do breathing exercises 8 hours a day, 10 times an hour", "interventionNames"=>["Behavioral: Respiratory physiotherapy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Routine treatment group", "description"=>"Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen.", "interventionNames"=>["Drug: Conservative Treatment"]}], "interventions"=>[{"name"=>"Respiratory physiotherapy", "type"=>"BEHAVIORAL", "otherNames"=>["Triflow"], "description"=>"In this group of patients, in addition to routine analgesic treatment, triflow use and deep breathing training would be given by the physiotherapist. Patients in this group will do breathing exercises 8 hours a day, 10 times an hour.", "armGroupLabels"=>["Respiratory physiotherapy group"]}, {"name"=>"Conservative Treatment", "type"=>"DRUG", "otherNames"=>["Control"], "description"=>"Patients in the control group will receive conservative treatment consisting of paracetamol and dexketoprofen.", "armGroupLabels"=>["Routine treatment group"]}]}, "ipdSharingStatementModule"=>{"timeFrame"=>"Data will be available permanently on 1.4.2025", "ipdSharing"=>"YES", "description"=>"Yes", "accessCriteria"=>"Upon reasonable request principal investigator will share date"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Kastamonu University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor Literally: Doctor Teaching Member", "investigatorFullName"=>"İsmail DAL", "investigatorAffiliation"=>"Kastamonu University"}}}}
