Evaluating Midline Catheters in Clinical Practice
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShandong Branden Med.Device Co.,Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Deemed unsuitable by investigator (e.g., poor compliance or inability to communicate clearly)
Refusal of informed consent by patient or family member
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Midline catheter placement
DevicePatients receive a midline catheter as part of their routine clinical care for intravenous therapy lasting 1 to 4 weeks
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From catheter insertion until removal, assessed up to 28 daysSecondary outcomes
1
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.
Time frame
At catheter removal, assessed up to 28 days2
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.
Time frame
At catheter insertion, assessed up to 28 days3
Catheter Dwell Time
Catheter dwell time is defined as the duration in days from successful catheter placement to catheter removal.
Time frame
From catheter insertion to removal, assessed up to 28 days4
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.
Time frame
From catheter insertion to removal, assessed up to 28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shandong Branden Med.Device Co.,Ltd
Lead sponsor
Zibo Central Hospital
Collaborator
Source ClinicalTrials.gov