Novel Medical Device for Pharmacological Therapy (Sechold)

April 14, 2025 updated by: Fundacion Miguel Servet

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

262

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31005
        • Recruiting
        • Hospital Universitario de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL
FIXATION OF VASCULAR ACCESSES WITH INFUSION OF THERAPY MAINTAINED IN THE TRADITIONAL WAY, DIRECTLY TO A THREE-WAY TAP AND EXTENSION FOR CONNECTION TO A CENTRAL DEVICE.
Experimental: INTERVENTION
FIXATION OF VASCULAR ACCESSES WITH INFUSION OF THERAPY MAINTAINED IN THE TRADITIONAL WAY, DIRECTLY TO THREE-WAY TAP AND EXTENSION FOR CONNECTION TO CENTRAL DEVICE INCORPORATING THE SECHOLD GRIP SYSTEM FOR ATTACHMENT OF MULTIPLE DROPPERS TO IT, WITH LABELING AND ATTACHMENT TO BED/CRADLE, DROPPER STICK OR PATIENT/CARRIER CLOTHING.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1, day 7, day 14, at 6 months after placement and start of the study
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
day 1, day 7, day 14, at 6 months after placement and start of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day 1, day 7, day 14, at 6 months after placement and start of the study

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1, day 7, day 14, at 6 months after placement and start of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Miguel Servet

Investigators

  • Principal Investigator: Marta M Ferraz-Torres, PHD, Fundacion Miguel Servet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

September 20, 2026

Study Registration Dates

First Submitted

April 4, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SecHold Baby

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe