Clinical trial NCT06135857: Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters in Patients Hospitalized in Critical Care Units.
Official title: Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters in Patients Hospitalized in Critical Care Units. Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thrombosis; Catheter, Infusion Catheter (Vascular)
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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