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NCT Number: NCT06944327

Reduction of Complications Associated With PICC Management

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

traditional care

Other

Traditional cure administration with sutureless device fixation every 7 days

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).

    Time frame: Measurement follow-up until removal or 6 and 12 months after catheter implantation.

    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

Secondary outcomes

  1. level of patient satisfaction related to various processes and frequencies of care

    Time frame: 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.

    use of a liker-type scale to determine the level of overall satisfaction with the care and handling of the device

Other outcomes

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

    Time frame: 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marta M Ferraz Torres, PhD

CONTACT

[email protected]

+34648668085 ext. 52377

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Collaborators

  • Complejo Hospitalario de Navarra

Registry information

Official study title

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

Acronym: PICC managemen

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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