Thrombosis; Catheter, Infusion Catheter (Vascular)ECOEMSNCT06135857
Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters
A study testing Protocol ECOEMS in people with Thrombosis; Catheter, Infusion Catheter (Vascular), run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thrombosis; Catheter, Infusion Catheter (Vascular)
- What is being tested?
- Protocol ECOEMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Being tested
- Protocol ECOEMS
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol ECOEMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Device: Protocol ECOEMS |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2023
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombosis; Catheter, Infusion Catheter (Vascular)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Althaia Xarxa Assistencial Universitària de Manresa
- Responsible party
- Principal investigator, Gerez Acevedo, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135857
- Sponsor's protocol ID
- 2023.151
- Acronym
- ECOEMS
- Status last verified
- Jun 2026
- First submitted
- 6 Nov 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06135857
- Acronym / sponsor ID
- ECOEMS / 2023.151
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Collaborators
- Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Althaia Xarxa Assistencial Universitària de Manresa
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Protocol ECOEMS |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocol ECOEMSUse 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. | Device | Intervention group |
Primary outcome
To know the effectiveness of electromuscular stimulation therapy in patients hospitalized in critical care units to prevent venous thrombosis related to PICC catheters.
Time frame: 15 days
Ultrasound will be used to measure whether or not there is the appearance of thrombosis related to the PICC catheter.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol ECOEMS in people with Thrombosis; Catheter, Infusion Catheter (Vascular), run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To know the effectiveness of electromuscular stimulation therapy in patients hospitalized in critical care units to prevent venous thrombosis related to PICC catheters. (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.