Reduction of Complications Associated With PICC Management (PICC managemen)

Fundacion Miguel Servet

Status: Begins enrollment in 4 months

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

Treatments: Procedure: MANAGEMENT CARE; Other: traditional care

Study type: Interventional

Funder types: Other

Identifiers

NCT06944327

Quality_PICC (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 4 patient groups, including a placebo group

PIVC fixed with SecurAcath 7 DAYS

Placebo Comparator group

Description:

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.

Treatment:

Other: traditional care

PIVC fixed with SecurAcath 14 DAYS

Experimental group

Description:

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.

Treatment:

Procedure: MANAGEMENT CARE

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

Experimental group

Description:

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.

Treatment:

Procedure: MANAGEMENT CARE

SecurAcath + Derma+ Flex® QS Skin Tissue Adhesive14 days

Experimental group

Description:

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.

Treatment:

Procedure: MANAGEMENT CARE