[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544180":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":55,"collaborators":57,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":26,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Hospital de Clinicas de Porto Alegre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tunneled PICC","EXPERIMENTAL","The intervention group will consist of adult patients who will have PICCs inserted using the catheter tunneling technique. The technique involves the catheter being exteriorized through the skin at a site different from the blood vessel puncture site, thus traversing a subcutaneous tunnel.",[13],"Procedure: Subcutaneous tunnelling",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-tunneled PICC","ACTIVE_COMPARATOR","The control group will consist of adults patients who will have PICCs inserted using the conventional technique",[19],"Procedure: Non-tunnelling",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Subcutaneous tunnelling","The Subcutaneous tunnelling group will undergo PICC placement under ultrasonography. Procedures will be implemented under hand hygiene, maximal sterile barrier, and chlorhexidine. The targeted arm will be sterilized with a mixture of chlorhexidine and isopropyl alcohol, and a sterile drape will be placed to cover the entire procedure feld from head to toe and place with additional subcutaneous tunnelling. After vein puncture with the access needle, a Nitinol guidewire will be placed as usual. We will make a tunnel distal to the initial venepuncture site using an additional 14-gauge needle. After resolution of the loop over the venepuncture site, a peel-away sheath will be placed over the wire. The catheter will be trimmed to the distance between the venepuncture site and cavoatrial junction plus the subcutaneous tunnel before being inserted in the usual manner.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Non-tunnelling","The Non-tunnelling group will have PICC placement with the traditional method under ultrasonography. Procedures will be implemented under hand hygiene, maximal sterile barrier, and chlorhexidine. The targeted arm will be sterilized with a mixture of chlorhexidine and isopropyl alcohol, and a sterile drape will be placed to cover the entire procedure feld from head to toe. After vein puncture with the access needle, a Nitinol guidewire will be placed. After, a peel-away sheath will be placed over the wire. The catheter will be trimmed to the distance between the venepuncture site and cavoatrial junction.",[15],[32],{"name":33,"affiliation":34,"role":35},"Eneida R Rabelo da Silva, ScD","Hospital de Clínicas de Porto Alegre","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","5551998068616","eneidarabelo@gmail.com",[42],{"facility":34,"status":43,"city":44,"state":26,"zip":26,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Porto Alegre","Brazil","BR",{"type":48,"coordinates":49},"Point",[50,51],-51.23019,-30.03283,{"lat":51,"lon":50},[54],{"name":33,"role":38,"phone":26,"phoneExt":26,"email":26},{"type":56,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[58,60],{"name":59,"class":6},"Hospital Moinhos de Vento",{"name":61,"class":6},"Irmandade Santa Casa de Misericórdia de Porto Alegre","100544180","tunneled-peripherally-inserted-central-catheter-picc-in-adult-patients-and-associated-outcomes-100544180",false,"NCT06365528","Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes","Tunneled Versus Non-Tunneled Peripherally Inserted Central Catheter and Their Effects on Reducing Combined or Isolated Outcomes (Obstruction, Infection, Thrombosis, and Dislodgement): Multicenter Randomized Clinical Trial","Inclusion Criteria:\n\n* adult patients (\\>= 18 years old) admitted to medical clinics, surgical clinics, or ICU, who have an indication for PICC insertion;\n\nExclusion Criteria:\n\n* patients with Chronic Kidney Disease, whether dialytic or not;\n* patients in critical or unstable condition characterized by the need for intubation, respiratory rate \\\u003C8 or \\>35 breaths per minute, oxygen saturation \\\u003C90%, heart rate \\\u003C40 or \\>140 beats per minute, systolic blood pressure \\\u003C90mmHg, decreased Glasgow Coma Scale \\>2 points, or prolonged (\\>5 minutes) or repeated seizures;\n* patients with cognitive deficits that impair their understanding of the study and do not have a responsible party to assist in this stage.","ALL","18 Years",{"count":72,"type":73},840,"ESTIMATED","INTERVENTIONAL",[76],"NA","The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days.",[79,80,81,82,83,84],"CLABSI - Central Line Associated Bloodstream Infection","Deep Vein Thrombosis","Dislodged Catheter","Occlusion","Catheter Rupture","Catheter (Other); Complications","2024-05-16",{"date":87,"type":88},"2024-05-20","ACTUAL",{"date":90,"type":88},"2024-05-06",{"date":92,"type":73},"2026-07-31",{"name":5,"class":6},1]