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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thrombosis; Catheter, Infusion Catheter (Vascular)
• Intervention / Treatment: Device: Protocol ECOEMS

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ines Gerez Acevedo; Phone Number: 636543624; Email: ines04081994@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group	Device: Protocol ECOEMS; Use electo estimulation therapy. The 4-channel stimulator will be used. The 6 electrodes will be located on the biceps, triceps and deltoids. Two daily sessions will be distributed, five days a week, lasting 20 minutes, the vascular program designed by the electro stimulation team itself will be applied.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: 2023.151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No