Evaluating Midline Catheters in Clinical Practice

A Prospective, Multicenter, Real-World Clinical Study Provides an Assessment of the Safety and Efficacy of Midline Catheters

The goal of this observational study is to learn about the safety and effectiveness of midline catheters in patients who receive midline catheter placement as part of their routine clinical care. The main question it aims to answer is:

Do midline catheters demonstrate acceptable safety and effectiveness when used in routine clinical practice?

Participants who receive a midline catheter as part of their regular medical care will have their clinical data collected from electronic medical records and patient questionnaires, and followed for outcomes related to catheter-related complications and functional performance.

Study Overview

• Status: Recruiting
• Conditions: Vascular Access Devices; Safety and Effectiveness of Midline Catheters
• Intervention / Treatment: Device: Midline catheter placement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Lina Zhang; Phone Number: +86-18678187002; Email: 1173565974@qq.com

Study Locations

• China
  • Zibo, China
    • Recruiting
    • Zibo Central Hospital
    • Contact: Lina Zhang; Phone Number: +86 18678187002; Email: 1173565974@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 years or older receiving a first-time midline catheter as part of their routine clinical care for intravenous therapy expected to last 1 to 4 weeks.

Description

Inclusion Criteria:

• Age ≥ 18 years
• First-time midline catheter placement per physician order
• Not enrolled in another clinical study
• Willing and able to provide informed consent and comply with follow-up (unless consent waived by local ethics committee)

Exclusion Criteria:

• Deemed unsuitable by investigator (e.g., poor compliance or inability to communicate clearly)
• Refusal of informed consent by patient or family member

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Catheter-Related Complications	Catheter-related complications include phlebitis, catheter-related bloodstream infection (CRBSI), venous thrombosis, and catheter occlusion. Complication rate is calculated as the number of participants experiencing at least one complication divided by the total number of enrolled participants, multiplied by 100 percent.	From catheter insertion until removal, assessed up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter Function Rate	Catheter function rate is defined as the proportion of participants whose catheter remains functional without any complications until removal. It is calculated as the number of participants with no complications and with functional catheter at removal divided by the total number of enrolled participants, multiplied by 100 percent.	At catheter removal, assessed up to 28 days
One-Time Insertion Success Rate	One-time insertion success is defined as successful placement of the catheter tip at the ideal position (axillary vein thoracic segment or subclavian vein) on the first attempt without need for repositioning, with the catheter functioning normally for infusion. The rate is calculated as the number of participants with one-time insertion success divided by the total number of enrolled participants, multiplied by 100 percent.	At catheter insertion, assessed up to 28 days
Catheter Dwell Time	Catheter dwell time is defined as the duration in days from successful catheter placement to catheter removal.	From catheter insertion to removal, assessed up to 28 days
Unplanned Removal Rate	Unplanned removal is defined as premature catheter removal due to complications or other causes before the planned completion of intravenous therapy. The rate is calculated as the number of participants with unplanned removal divided by the total number of enrolled participants, multiplied by 100 percent.	From catheter insertion to removal, assessed up to 28 days
Insertion and Maintenance Cost	Insertion and maintenance cost includes all expenses associated with catheter placement (device cost, insertion procedure, anesthesia, ultrasound guidance if used) and catheter care (dressing changes, flushing, site care, and complication management).	From catheter insertion to removal, assessed up to 28 days
Patient Satisfaction	Patient satisfaction is assessed at catheter removal using a 5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied). The satisfaction rate is calculated as the number of participants rating 4 or 5 divided by the total number of participants who completed the survey, multiplied by 100 percent.	At catheter removal, , assessed up to 28 days

Collaborators and Investigators

• Sponsor: Shandong Branden Med.Device Co.,Ltd
• Collaborators: Zibo Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: June 13, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Midline catheters, vascular access devices, catheter-related complications, patient safety, real-world study
• Other Study ID Numbers: Branden-MRW2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No