Reduction of Complications Associated With PICC Management

NCT06944327 | Not Yet Recruiting

• 1 other identifier: Quality_PICC
• Study Type: interventional
• Target: 460
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Treatment Outcome; Vascular Access; Vascular Access Device; Vascular Access Complication; Care Delivery; Nurse; Nurse Based Care Management

Keywords

vascular; vascular access; catheter; central catheter; nurse; vascular access device; management; complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• level of patient satisfaction related to various processes and frequencies of care

  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 Outcomes (1)

• Recognize the cost-effectiveness of each of the randomization groups included in the study.

  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

Study Arms (4)

PIVC fixed with SecurAcath 7 DAYS

PLACEBO COMPARATOR

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

PIVC fixed with SecurAcath 14 DAYS

EXPERIMENTAL

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

PIVC fixed with SecurAcath with Derma+ Flex® QS Skin Tissue Adhesive 7 days

EXPERIMENTAL

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

SecurAcath + Derma+ Flex® QS Skin Tissue Adhesive14 days

EXPERIMENTAL

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

Interventions

MANAGEMENT CARE PROCEDURE

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.

PIVC fixed with SecurAcath 14 DAYS; PIVC fixed with SecurAcath with Derma+ Flex® QS Skin Tissue Adhesive 7 days; SecurAcath + Derma+ Flex® QS Skin Tissue Adhesive14 days

traditional care OTHER

Traditional cure administration with sutureless device fixation every 7 days

PIVC fixed with SecurAcath 7 DAYS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Complejo Hospitalario de Navarra: collaborator

Central Study Contacts

Marta M Ferraz Torres, PhD

CONTACT

+34648668085; marta.ferraz.torres@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To conduct effective masking in a quasi-experimental study of catheter care, it is critical to implement a design that minimizes bias for both patients and investigators. First, patients should be randomly assigned to different intervention groups, ensuring that they have no knowledge about the type of care they will receive (e.g., standard care versus a new care protocol). This can be accomplished through the use of sealed envelopes or an online allocation system that keeps randomization hidden. On the other hand, investigators assessing outcomes should also be masked to patient assignment; this can be achieved by forming an independent team to perform the assessments and data analysis, without access to information about which group each patient belongs to. In addition, training should be provided to all personnel involved in the study to ensure that blinding procedures are followed and the integrity of the study is maintained. In this way, biases are minimized and the validity of th
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized prospective longitudinal design, by means of a representative sample selection of the study population, in a simple randomized fashion. The study will be conducted and piloted at the Hospital Universitario de Navarra, in the Intravenous Therapy Unit (ITU). A certain number of patients who meet the inclusion criteria (representative sample of the population to be studied) will be registered and analyzed during the same period (6 months) to determine and record the study variables and outcome data. In this case, the inclusion criteria for taking part in the study will be all patients over 18 years of age, with a level of independence for optimal care and attended in the ICU for the insertion of a long-term PIVC device who voluntarily accept to participate in the study. As selection criteria, all cases of dependent, bedridden and hemodynamically unstable patients will be considered as exclusion criteria, as well as all users who, after informing the patients or legal guardians

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share