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Comparison of Clinical Outcomes of Mini Midline Catheters With Different Placement Sites: a Randomized Controlled Trial

NCT06106659 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-04-11

No results posted yet for this study

Summary

Peripheral venous catheters are the most commonly used vascular access devices in healthcare today, including indwelling needles, mini-midline catheters, and medium-length venous catheters. Peripheral venous catheters are required due to clinical needs for prescribed intravenous treatments, medications, surgical procedures, or diagnostics, such as computed tomography scans, etc. One study noted that more than 70% of hospitalized patients had indwelling needles placed. However, post-placement failure of indwelling needles occurs in 30%-50% of patients before completing treatment, unplanned catheter failure occurs in 69% of patients before completing treatment, and there is a 30%-60% risk of various complications. And patients are often subjected to repeat catheter placement, such as improper catheter placement or improperly entered medications. In addition, catheterization is prone to infectious and noninfectious complications, and the risk of phlebitis increases 4.4-fold when catheters are reintroduced.Tan et al. found that the average number of indwelling needle insertions per patient admission was 2.82, and therefore, approximately 44% of adult patients required more than one indwelling needle to complete IV therapy during their hospitalization. According to Helm et al, multiple insertions of indwelling needles per patient lead to unnecessary pain and anxiety, and multiple attempts per insertion further increase the risk of complications. These also lead to prolonged hospitalization, additional healthcare costs, pain, anxiety, and other adverse experiences.

Conditions

  • Catheter Complications

Interventions

DEVICE

Mini Midline

The tube was placed in the upper arm in the test group and in the forearm in the control group. The veins were selected according to anatomical criteria (vein diameter and depth), and the puncture site was protected with a sterile cavity towel. The cannulation nurse wore sterile gloves and injected local anesthesia (1 mL of lidocaine) before venipuncture. Venipuncture was always performed using real-time ultrasound-guided visualization of the vein-guiding needle using an "out-of-plane" approach, and once the tip of the needle was visualized within the vein and the blood flowed back through the needle, a guidewire was introduced and the needle was removed. After the needle is removed, the cannula is advanced into the vein, the guidewire is removed, and the cannula is attached to an extension cord closed with a needleless connector.

Sponsors & Collaborators

  • Sir Run Run Shaw Hospital

    lead OTHER

Principal Investigators

  • Linfang Zhao · Sir Run Run Shaw Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-09
Primary Completion
2024-01-24
Completion
2024-01-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06106659 on ClinicalTrials.gov