Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters in Patients Hospitalized in Critical Care Units.

Not Applicable

Not yet recruiting

• Conditions: Thrombosis; Catheter, Infusion Catheter (Vascular)
• Interventions: Device: Protocol ECOEMS

• Registration Number: NCT06135857
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Brief Summary

Introduction: The placement of a peripheral inserted central catheter (PICC) is a common practice in the hospital setting. However, despite all the advances reported, venous devices are not free of complications and catheter-related thrombosis (CRT), being one of the most prevalent. Electro muscular stimulation therapy can be a measure for the prevention of CRT. Objective: To know the efficacy of electro muscular stimulation therapy in patients hospitalized in critical care units to prevent venous thrombosis related to PICC catheters. Methodology: A multicenter Randomized Clinical Trial (RCT) will be carried out at the Dr. Josep Trueta University Hospital in Girona, Hospital del Mar in Barcelona, Althaia Foundation in Manresa. With a total of 68 patients with PICC catheters in critical care units, they will be randomly assigned to the intervention group (n=34) to whom, in addition to the usual protocolized care related to the vascular catheter, will be applied e Eco-EMS protocol, or the control group (n=34) to which only the usual protocolized care related to the vascular catheter was applied. Intervention: It will consist of the application of electrostimulation therapy five days a week, two daily sessions of 20 minutes in the intervention group. Both groups underwent five ultrasound examinations after the placement of the PICC to determine the appearance of CRT. Expected results: It is expected to observe that the application of the Eco-EMS protocol reduces thrombosis in the patients of the intervention group, compared to those of the control group.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-13
• Last Update Submitted: 2023-11-13
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Study Start: 2023-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Patients admitted to the critical unit with a PICC whose insertion is done by the EIAV of the same hospital.
• Patients between 18 and 80 years of age.
• Treatments related to the device protocolized by the same hospital as the EIAV implanter.

Exclusion Criteria

• Patients who do not sign informed consent.
• Patients with pacemakers and/or implantable automatic defibrillators.
• Patients with epilepsy.
• Removal of the device within the first 15 days after insertion.
• Hospital discharge, transfer to another hospital or death lethalis during the duration of the study.
• Displacement of the tip of the catheter outside the lower ⅓ of the superior vein cava during the study period.
• Presence of lesions in the place where the electrodes must be placed to perform the electrostimulation therapy.
• Non-compliance with catheter monitoring: Of the five ultrasound controls protocolized in the study, 80% were not complied with.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Protocol ECOEMS	-

Primary Outcome Measures

Name	Time	Method
To know the effectiveness of electromuscular stimulation therapy in patients hospitalized in critical care units to prevent venous thrombosis related to PICC catheters.	15 days	Ultrasound will be used to measure whether or not there is the appearance of thrombosis related to the PICC catheter.