protocolSection identificationModule nctId: NCT06314620, orgStudyIdInfo id: FF-2024-043, briefTitle: Normal Saline Flushing With And Without Heparin Lock In Maintaining Small Bore Intercostal Chest Catheter (ICC) Patency, acronym: SENSHIP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: National University of Malaysia, class: OTHER, descriptionModule briefSummary: Pleural diseases are among the most common clinical problems encountered in healthcare settings in Malaysia and even worldwide. Most patients presented in a hospital setting with pleural diseases will need pleural aspirations or thoracentesis and chest drains for a variety of reasons. Healthcare providers will often be exposed to patients requiring pleural drainage hence it is important to be aware of safe techniques and procedures of insertion and also maintaining the pleural drainage systems to yield beneficial results.Most often, smaller catheters were deemed to be less effective in view of slower drainage rates and associated with high risk of blockage. However presently, in tertiary hospital settings small bore intercostal chest catheters (SBICC) have become an alternative to large bore intercostal catheters (LBICC). SBICC has been found to be equally effective, less painful and easily tolerated by patients. Hence, proper maintenance of SBICC should be undertaken to reduce rates of occlusion and to yield most benefits from the pleural aspirations procedures.British Thoracic Society in their latest guidelines recommends the use of small bore intercostal chest drain as the first choice in draining pleural effusions.The success of draining pleural effusions with a SBICC has shown variable rates of success among different studies conducted. Most common issues faced are drain blockage and drain dislodgement.There is limited data comparing the use of normal saline flushing versus fibrinolytic drug lock in maintaining patency of small bore intercostal chest drains in draining pleural effusions. This has lead us in conducting this research to compare the rates of partial or complete occlusions among normal saline flush with and without heparin saline lock in maintaining the patency of small bore intercostal chest catheter among patients with pleural diseases in Hospital Canselor Tuanku Muhriz, UKM requiring chest drains insertion., conditionsModule conditions: Pleural Effusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Heparin saline lock, interventions name: Without heparin saline lock, outcomesModule primaryOutcomes measure: To compare the rate (in percentage) of occlusions of intercostal chest catheter in participants underwent normal saline flushing with and without heparin lock, secondaryOutcomes measure: To determine the onset of intercostal chest catheter occlusions (in hours), secondaryOutcomes measure: To determine the change of hemoglobin (in g/dL) post ICC insertion, secondaryOutcomes measure: To determine the change of platelet (in 10 9/L) post ICC insertion, secondaryOutcomes measure: To determine the adverse effects of heparin saline lock, secondaryOutcomes measure: To assess the number of fenestrations occluded (in numbers from 0-5) with fibrin or blood clots, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National University of Malaysia, status: RECRUITING, city: Kuala Lumpur, state: Wilayah Persekutuan, zip: 53300, country: Malaysia, contacts name: Mohamed Faisal Abdul Hamid, role: CONTACT, phone: 0391455555, phoneExt: 6082, email: faisal.hamid@ppukm.ukm.edu.my, geoPoint lat: 3.1412, lon: 101.68653, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-02-17, uploadDate: 2024-03-13T04:03, filename: Prot_SAP_ICF_000.pdf, size: 521443, hasResults: False