Novel Medical Device for Pharmacological Therapy (Sechold)

Fundacion Miguel Servet

Status: Enrolling

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

Treatments: Device: SECHOLD DEVICE

Study type: Interventional

Funder types: Other

Identifiers

NCT06938750

SecHold Baby

Details and patient eligibility

About

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.

Enrollment: 262 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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262 participants in 2 patient groups

CONTROL

No Intervention group

Description:

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.

INTERVENTION

Experimental group

Description:

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.

Treatment:

Device: SECHOLD DEVICE