Evaluating Midline Catheters in Clinical Practice

Study Title

A prospective multicenter real-world clinical study provides an assessment of the safety and efficacy of midline catheters

Study Description

Background and Why This Study Is Being Done

Midline catheters are intended for patients expected to require intravenous therapy for 1 to 4 weeks. They offer several advantages including rapid insertion, a high safety profile, low maintenance costs, and no need for X-ray confirmation of tip placement. Although midline catheters are widely used in clinical practice internationally, their adoption in China has been relatively late. Research on midline catheters in China remains limited and in its early stages without in-depth investigation.

This large-scale prospective multicenter real-world study, therefore, aims to provide robust data on the actual clinical use, safety, and effectiveness of midline catheters in China. The findings will support the standardization of midline catheter promotion, improvement, and operational and maintenance protocols.

Study Objectives

This study has two primary objectives. The first is to evaluate the real-world clinical application, safety, and effectiveness of midline catheters in China. The second is to identify risk factors associated with midline catheter-related complications, thereby defining target populations for focused intervention and providing evidence-based guidance for the development of preventive strategies.

Overall Study Design

This is a prospective multicenter observational real-world study. It plans to enroll approximately 10,000 patients receiving a midline catheter across 40 hospitals nationwide. Participants will be followed until catheter removal with observation and documentation of any complications occurring during the catheter dwell time.

Data analysis will include patient baseline characteristics, complication data, and catheter application data. These data will be used to evaluate the clinical safety and effectiveness of midline catheters. Logistic regression analysis will be performed to explore risk factors for complications. In addition, descriptive analysis of indications, catheter dwell time, and insertion and maintenance costs will help characterize the most common applications, the average dwell time, and the associated expenses.

Who Can Participate (Eligibility Criteria)

Inclusion criteria are being age 18 years or older, receiving a midline catheter for the first time as prescribed by a physician, not currently participating in any other clinical study, being alert and oriented with willingness to voluntarily participate and sign informed consent (unless the local ethics committee waives the consent requirement), and having the ability to comply with follow-up.

Exclusion criteria include being deemed unsuitable for participation by the investigator (for example due to poor compliance or inability to communicate clearly) or the patient or family member refusing to sign informed consent.

Study Endpoints

The study will assess the following outcomes. "Catheter-related complication rate" refers to the frequency of complications such as infection, occlusion, and thrombosis. Catheter function rate is the proportion of catheters functioning as intended without failure. One-time insertion success rate means successful placement on the first attempt. Catheter dwell time is the duration from insertion to removal. Unplanned removal rate indicates premature removal due to complications or failure. Insertion and maintenance costs are the total expenses associated with catheter placement and care. Patient satisfaction is the patient-reported satisfaction with the catheter experience.

Observation Period and Follow-Up Schedule

Follow-up assessments will occur during routine maintenance visits at the following time points if the catheter remains in place. These time points are 7 ± 3 days post-insertion, 14 ± 3 days post-insertion, 21 ± 3 days post-insertion (if applicable), and 28 ± 3 days post-insertion (if applicable). For catheters remaining in place beyond 28 days, follow-up will continue at each routine maintenance visit until removal. A participant is considered to have completed the study when the catheter is removed either because treatment has ended or due to a complication. Participants do not need to complete all scheduled follow-up time points.

Data Source

Study data will be collected through case report forms from multiple sources, including hospital electronic medical record systems, laboratory test results, outpatient prescription records, catheter maintenance records, insertion and maintenance cost data, and patient-completed questionnaires.

Sample Size and Rationale

This study is a prospective observational study rather than a standard interventional clinical trial. As such, the sample size is not based on a statistical calculation or a predetermined number. Instead, enrollment is limited to patients who meet all inclusion criteria, have no exclusion criteria, and actually receive a midline catheter at a participating hospital during the study period. The study expects to enroll approximately 10,000 midline catheter recipients across 40 hospitals nationwide.