Reduction of Complications Associated With PICC Management (PICC managemen)

Reduction of Complications Associated With PICC Management. Randomization in Care.

The present study aims to analyze different care routes of the peripheral access central venous catheter to assess which alternative allows a moderate reduction in the level of complications associated with prolonged care frequency, due to the reduction of device manipulation.

A high level of patient satisfaction is detected due to the controlled follow-up of the device care, as well as a decrease in the need for transfer to a center for follow-up.

Objective: Identify the type of care frequency for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (thrombosis, phlebitis, accidental removal, obstruction).

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Access; Vascular Access Complication; Treatment Outcome; Nurse; Vascular Access Device; Nurse Based Care Management; Care Delivery
• Intervention / Treatment: Other: traditional care; Procedure: MANAGEMENT CARE

Detailed Description

Study variables and measurement instruments:

Sociodemographic and control variables: age and sex, reason for admission, clinical diagnosis, day of care.

Device-related variables: Catheter type, brand, access type, caliber, number of lumens, infusion/pharmacological therapy, number of simultaneous therapies, days of access cannulation, frequency of care, antiseptic used in access manipulation, 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 the patient with information and sign a consent form prior to participation in the study. After the insertion process, the device placement representative will record the device characteristics and relevant aspects of the insertion, generating a 1-1 random assignment of the study participation group.

This assignment will be done by giving the patient a code during the data entry process. This will allow for blinding of subsequent data collection and proper, anonymous follow-up of the case.

Once insertion is complete, the device will be secured by applying Dermabond Mini glue (2-Octyl Cyanoacrylate), the SecurAcath system (a subcutaneous stabilization device that does not require changing while the catheter is in place), and a semi-transparent dressing (3M Tergaderm fully reinforced membrane (TSM) dressing), which will allow for monitoring the 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, will be conducted by a trained professional dedicated exclusively to this care. Follow-up data will be collected: date of treatment, treatment and elements used, and findings on the device or patient. The follow-up process will be blinded at all times by both the professional and the patient.

After the established 6-month follow-up period, a patient satisfaction questionnaire will be completed, and the coded data will be reported for assessment and interpretation by the research team.

Likewise, an analysis of the economic costs involved in each care frequency will be performed, thanks to the collaboration of the center's financial management service, which will calculate the average 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 the data and all participants. The results will be recorded in the SPSS statistical software so 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 an institution that collaborates with some team members.

Ethical Aspects:

A request from the Research Ethics Committee has been made. Likewise, information for participants and family members is ensured through a written report that includes a comprehensive explanation of the project and participant rights. This report will be delivered after verbal communication and any questions are resolved. After verbal acceptance of participation in the process, a paper informed consent form is provided for the patient or legal guardian to sign.

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta M Ferraz Torres, PhD; Phone Number: 52377 +34648668085; Email: marta.ferraz.torres@navarra.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• be over 18 years of age
• accept participation in the study
• independent patient in the care and management of activities of daily living

Exclusion Criteria:

• patient over 18 years of age
• patient with functional or cognitive limitation
• patient with mild, moderate or high level of dependence
• patient does not accept to perform the study
• patient with device withdrawal prior to 14 days of duration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: PIVC fixed with SecurAcath 7 DAYS; G1: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and semitransparent dressing change (Tergaderm 3M fully reinforced membrane dressing (TSM) every 7 days.	Other: traditional care; Traditional cure administration with sutureless device fixation every 7 days
Experimental: PIVC fixed with SecurAcath 14 DAYS; G2: PIVC fixed with SecurAcath, with care performed by heparinization with push-stop-push technique and positive pressure + fibrillin and dressing change dressing 7 semitransparent (fully reinforced membrane dressing (TSM) Tergaderm 3M every 14 days.	Procedure: MANAGEMENT CARE; Administration of the sealing element after canalization and initial treatment of the device, prior to fixation with a suture system and a 7-day vs. 14-day cadence test.
Experimental: PIVC fixed with SecurAcath with Derma+ Flex® QS Skin Tissue Adhesive 7 days; G3: PIVC fixed with SecurAcath PLUS Derma+ Flex® QS Skin Tissue Adhesive, with care performed by heparinization with push-stop-push technique and positive pressure + sealing solution + saline and semitransparent dressing change (Tergaderm 3M fully reinforced membrane dressing (TSM) every 7 days.	Procedure: MANAGEMENT CARE; Administration of the sealing element after canalization and initial treatment of the device, prior to fixation with a suture system and a 7-day vs. 14-day cadence test.
Experimental: SecurAcath + Derma+ Flex® QS Skin Tissue Adhesive14 days; PIVC fixed with SecurAcath PLUS Derma+ Flex® QS Skin Tissue Adhesive, with care performed by heparinization with push-stop-push technique and positive pressure + saline + sealing solution+ saline and semitransparent dressing change (Tergaderm 3M fully reinforced membrane dressing (TSM) every 14 days.	Procedure: MANAGEMENT CARE; Administration of the sealing element after canalization and initial treatment of the device, prior to fixation with a suture system and a 7-day vs. 14-day cadence test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify the type of frequency of care for PIVCs most beneficial for the reduction of complications associated with extraluminal device care (LESS thrombosis, phlebitis, accidental removal, obstruction).	Reduction of complications such as thrombosis, phlebitis, accidental withdrawals, obstruction. measurement of the various complications according to: number of associated complications per device according to intervention group	Measurement follow-up until removal or 6 and 12 months after catheter implantation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of patient satisfaction related to various processes and frequencies of care	use of a liker-type scale to determine the level of overall satisfaction with the care and handling of the device	day 1, day 7, day 14, at 6 months after placement and start of the study of the device and at 12 months after the device is removed.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recognize the cost-effectiveness of each of the randomization groups included in the study.	Measurement of direct and indirect costs of device care by study group, taking into account whether there are complications and the costs associated with them.	day 1, day 7, day 14, at 6 months after placement and start of the study of the device and at 12 months after the device is removed. at 6 months after placement and start of the study of the device and at 12 months after the device is removed

Collaborators and Investigators

• Sponsor: Fundacion Miguel Servet
• Collaborators: Complejo Hospitalario de Navarra

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: nurse; management; vascular; vascular access; complication; catheter; vascular access device; central catheter
• Other Study ID Numbers: Quality_PICC (Other Identifier: Fundacion Miguel Servet)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No