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

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)

Overall Status

Completed

CT.gov ID

NCT04391205

Collaborator

(none)

211

Enrollment

Location

22.1

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Upper Extremity Deep Vein Thrombosis, Secondary

Study Design

Study Type:

Observational

Actual Enrollment :

211 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 26, 2017

Actual Primary Completion Date :

Feb 28, 2019

Actual Study Completion Date :

Feb 28, 2019

Outcome Measures

Primary Outcome Measures

Number of participants with Peripheral deep venous thrombosis (DVP) suspected with Compression ultrasound (CUS) and confirmed by echodoppler [Once a week from the implant day until CVP removal or patient discharge, whichever came first, assessed up to 40 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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