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Novel Medical Device for Pharmacological Therapy

NCT06938750 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2025-04-22

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

SECHOLD 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.

Sponsors & Collaborators

  • Fundacion Miguel Servet

    lead OTHER

Principal Investigators

  • Marta M Ferraz-Torres, PHD · Fundación Miguel Servet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2026-01-31
Completion
2026-09-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938750 on ClinicalTrials.gov