A Study to Investigate the Possible Causes of Secondary Effects During Use of Peripheral Midline Type Catheter in Patients Hospitalized in Different Care Settings

Upper Extremity Deep Vein Thrombosis, Secondary Clinical Trial

— MIDES  

Official title:

Safety and Efficiency oh the Use of Midline Peripheral Venous Catheter (MIDES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391205
• Other study ID #: 0041902
• Status: Completed
• Start date: April 26, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2020
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Although the use of peripheral venous catheters (CVP) with brachial insertion with echo-guide (Midline) has increased significantly over the last 5-10 years, there are no sensitive data concerning complications in the literature during their use, particularly as regards incidence of thrombotic complication.The prospective observational study will enroll all the patients admitted to Home Health Hospitalization service, Geriatric Department and Intermediate Care service, to whom a Midline-type CVP will be placed for infusional therapy and who will give their consent to participate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Subjects admitted to wards adhering to the study (Home Health Hospitalization service, Geriatric Department and Intermediate Care service)

• Subjects submitted to Midline type venous catheter insertion

Exclusion Criteria:

• History of deep venous thrombosis or pulmonary embolism

• Be hospitalized for less than a week

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Thrombosis
• Upper Extremity Deep Vein Thrombosis
• Upper Extremity Deep Vein Thrombosis, Secondary
• Venous Thrombosis

Locations

Country	Name	City	State
Italy	Marinello Renata	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Peripheral deep venous thrombosis (DVP) suspected with Compression ultrasound (CUS) and confirmed by echodoppler	Deep vein thrombosis is investigated with Compression ultrasound (CUS) technique, scheduled once a week from the implant day or performed at the time of occurrence of device malfunctions or at the onset of symptoms resulting from thrombotic complications; echodoppler tecnique is used to confirm diagnosis of thrombosis.	Once a week from the implant day until CVP removal or patient discharge, whichever came first, assessed up to 40 days