Authors
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Fundacion Miguel Servet -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Study variables and measurement instruments:Sociodemographic and control variables: age and sex, reason for admission, clinicaldiagnosis, day of care. Device‐related variables: Catheter type, brand, access type,caliber, number of lumens, infusion/pharmacological therapy, number of simultaneoustherapies, days of access cannulation, frequency of care, antiseptic used in accessmanipulation, dressing and fixation system, other device care, direct and indirect costs.Dependent variables: Complications (infectious, mechanical, chemical, or thrombotic),reason for removal and accidental dislodgement, cost, patient satisfaction level.Data collection:The catheter will be inserted by the Intravenous Therapy Unit, which will provide thepatient with information and sign a consent form prior to participation in the study.After the insertion process, the device placement representative will record the devicecharacteristics and relevant aspects of the insertion, generating a 1‐1 random assignmentof the study participation group. This assignment will be done by giving the patient acode during the data entry process. This will allow for blinding of subsequent datacollection and proper, anonymous follow‐up of the case. Once insertion is complete, thedevice will be secured by applying Dermabond Mini glue (2‐Octyl Cyanoacrylate), theSecurAcath system (a subcutaneous stabilization device that does not require changingwhile the catheter is in place), and a semi‐transparent dressing (Tergaderm fullyreinforced membrane (TSM) dressing wich clorhexidine), which will allow for monitoringthe insertion site and randomizing care.Once the study group has been assigned and the device has been placed, patient follow‐up,including standardized device treatment at 7 days and the other goup with the same carebut in a cadence of 15 days. this will be conducted by a trained professional dedicatedexclusively to this care. Follow up data will be collected: date of treatment, treatmentand elements used, and findings on the device or patient. The follow‐up process will beblinded at all times by both the professional and the patient. After the established12‐month follow‐up period, a analisys of the results and complications will be maked.also, a patient satisfaction questionnaire will be completed, and the coded data will bereported for assessment and interpretation by the research team. Likewise, an analysis ofthe economic costs involved in each care frequency will be performed, thanks to thecollaboration of the center's financial management service, which will calculate theaverage direct and indirect costs resulting from each care frequency.Data Analysis:The collected data will be pre‐coded by the research team, ensuring the anonymity of thedata and all participants. The results will be recorded in the SPSS statistical softwareso that they can be analyzed and processed directly. For analysis and interpretation,support is provided by statistical experts within the research group, as well as by aninstitution that collaborates with some team members.Ethical Aspects:A request from the Research Ethics Committee has been made. Likewise, information forparticipants and family members is ensured through a written report that includes acomprehensive explanation of the project and participant rights. This report will bedelivered after verbal communication and any questions are resolved. After verbalacceptance of participation in the process, a paper informed consent form is provided forthe patient or legal guardian to sign
Epistemonikos ID: 9ffbd4ca7c85814e89584f55751d605700eca239
First added on: Sep 03, 2026