Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06135857
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-06
Brief Title:
Electromuscular Stimulation Therapy as a Prophylactic Method to Reduce Thromboses Related to PICC Catheters in Patients Hospitalized in Critical Care Units
Sponsor:
Institut dInvestigació Biomèdica de Girona Dr Josep Trueta
Organization:
Institut dInvestigació Biomèdica de Girona Dr Josep Trueta
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECOEMS
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 n34 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 n34 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None