Clinical trial NCT06938750: Novel Medical Device for Pharmacological Therapy
Official title: A Pilot Study of a Novel Medical Device for Pharmacological Therapy: The SecHold Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Access
Vascular Access Complication
Vascular Access Complications
Catheter Malfunction
Catheter Infection
Therapeutic Drug Management
Nurse
Nurse Based Care Management
Innovative Procedures
Keywords: VASCULAR ACCESS
CATHETER
THERAPY
COMPLICATION
DEVICE
CENTRAL VASCULAR ACCESS
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 262
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A clinical trial was carried out in an intensive care unit of the University Hospital of Navarra, a tertiary hospital reference center in intensive care in Navarra, in the north of Spain; where the use and clinical validation process of a newly created device registered by European patent as a utility model was implemented. This study was made over a period of 6 months, from June 2021 to December of the same year; after internal authorization from the center where the clinical validation process has been carried out and from the local ethics committee (pyto2019/47).
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To reduce the risk of complications associated with the number of pharmacological errors.
timeFrame: day 1, day 7, day 14, at 6 months after placement and start of the study
measure: To reduce complications associated with accidental catheter withdrawals.
timeFrame: day 1, day 7, day 14, at 6 months after placement and start of the study
Secondary outcomes:
measure: Reduce complications associated with venous catheter placement and maintenance (thrombosis, phlebitis, catheter obstruction).
timeFrame: day 1, day 7, day 14, at 6 months after placement and start of the study
Other outcomes:
measure: Improved satisfaction of healthcare professionals operating the device.
timeFrame: day 1, day 7, day 14, at 6 months after placement and start of the study
Locations:
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
Study officials:
affiliation: Fundación Miguel Servet
name: Marta M Ferraz-Torres, PHD
role: PRINCIPAL_INVESTIGATOR
References: