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

NCT06106659 | Completed

• 1 other identifier: 2023-802-01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of catheter-related complications

  Catheter-related complications included phlebitis, catheter-related thrombosis, catheter-related infection, catheter occlusion, catheter prolapse, blood leakage, and fluid leakage, and the incidence rate of each complication was the number of patients with the complication/total number of patients. The total incidence of catheter-related complications was the main outcome indicator, i.e., the number of patients with complications/the total number of patients, and the occurrence of one or more complications in the same patient was counted as one case.

  during catheter indwelling procedure

Study Arms (2)

forearm

EXPERIMENTAL

Mini midline catheter forearm placement.

Device: Mini Midline

upper arm

OTHER

Mini midline catheter upper arm placement

Device: Mini Midline

Interventions

Mini Midline DEVICE

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.

forearm; upper arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The expected duration of IV fluids before placement is 1-4 weeks.
• Intravenous fluids are used only during hospitalization.
• The nature of the infused drugs is in accordance with the indications for peripheral venous catheters.
• Conscious and able to communicate normally.
• Voluntarily participate in this study and sign the informed consent form.

You may not qualify if:

• History of radiation therapy, thrombosis, and trauma at the site of placement.
• Vulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, pregnant women, illiterates, etc.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Linfang Zhao

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Cano A, Ettcheto M, Espina M, Lopez-Machado A, Cajal Y, Rabanal F, Sanchez-Lopez E, Camins A, Garcia ML, Souto EB. State-of-the-art polymeric nanoparticles as promising therapeutic tools against human bacterial infections. J Nanobiotechnology. 2020 Oct 31;18(1):156. doi: 10.1186/s12951-020-00714-2.

  PMID: 33129333 BACKGROUND

Study Officials

• Linfang Zhao

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant nursing director

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 30, 2023
• Study Start: October 9, 2023
• Primary Completion: January 24, 2024
• Study Completion: January 24, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)