CompletedNot Applicable

Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters

Spain120 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To know the effectiveness of electromuscular stimulation therapy in patients hospitalized in critical care units to prevent venous thrombosis related to PICC catheters.

Timeframe: 15 days

Trial details

NCT IDNCT06135857

SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More Thrombosis; Catheter, Infusion Catheter (Vascular) trials