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NCT Number: NCT06938750

Novel Medical Device for Pharmacological Therapy

Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.

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Key information

Conditions

Vascular Access Catheter Infection Catheter Malfunction Innovative Procedures Nurse Nurse Based Care Management Therapeutic Drug Management Vascular Access Complication Vascular Access Complications

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Navarra

Pamplona, Navarre, 31005, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients admitted to the intensive care unit
  • patients with authorization to take part in the study

Exclusion criteria

  • Patients with pre-existing medical conditions: Patients with diseases affecting coagulation, such as hemophilia or thrombocytopathies, could be excluded.
  • Active infection patients: Any patient with vascular access site infections or systemic infections may be excluded to avoid complications.
  • Inability to give informed consent: Patients who are unable to understand or consent to participate in the study.

Treatment and study plan

SECHOLD DEVICE

Device

PLACEMENT OF A MULTIPLE THERAPY GRIPPING DEVICE TO FIX THE DRIPPER SYSTEMS ALONG ITS PATH TO SOME SURFACE OR SPACE, AVOIDING IT TO REMAIN IN THE AIR, WITHOUT MARKING OR LABELING AND FAVORING ITS ORGANIZATION. SECHOLD is a vascular access fixation device designed for critical clinical environments such as ICU and operating rooms. It allows the simultaneous connection of 3-6 parenteral therapies to the same vascular access, ensuring clear and protocolized identification of each drug by means of labels with name, concentration and infusion range, in addition to a universal color code. This reduces the risk of drug administration errors and facilitates optimal visualization of essential information. SECHOLD also organizes infusion systems connected to the same vascular access, preventing knots and pulls that can compromise catheter integrity in case of accidental infusion bag drops.

Primary outcomes

  1. To reduce the risk of complications associated with the number of pharmacological errors.

    Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study

    Recognize the number of pharmacological errors (DRUG INTERACTION, WRONG DRUG, WRONG DOSAGE, WRONG SPEED) that have occurred

  2. To reduce complications associated with accidental catheter withdrawals.

    Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study

    Number of complications associated with accidental catheter withdrawals during the study period

Secondary outcomes

  1. Reduce complications associated with venous catheter placement and maintenance (thrombosis, phlebitis, catheter obstruction).

    Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study

    Number of complications associated with venous catheter placement and maintenance (thrombosis, phlebitis, catheter obstruction)

Other outcomes

  1. Improved satisfaction of healthcare professionals operating the device.

    Time frame: day 1, day 7, day 14, at 6 months after placement and start of the study

    Satisfaction Questionnaire:

    A form used in the workplace with an overall satisfaction level will be used with a Liker scale of 1-10, with 1 being not at all satisfactory and 10 being maximum satisfaction.

Study contacts

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

marta M FERRAZ-TORRES, PHD

CONTACT

[email protected]

+34628813974

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Registry information

Official study title

A Pilot Study of a Novel Medical Device for Pharmacological Therapy: The SecHold Device

Acronym: Sechold

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Apr 22, 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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