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A Multicentre Pilot Study of Midline Catheter's Tip at a Different Position in Antimicrobial Therapy

Midline Catheter Tip Position and Catheter-Related Complications in Antimicrobial Therapy- A Multi-centre Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04601597
Enrollment
330
Registered
2020-10-26
Start date
2020-08-12
Completion date
2021-01-30
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Infection nursing

Brief summary

The research protocol was based on assigning patients to three different catheter tip groups and then observing the relationship between the tip and catheter-related complications when infusing antimicrobial agents.

Detailed description

A prospective case-control observation study method was adopted. The investigators of each center included patients who met the inclusion and exclusion criteria and were fully informed about the content of the study, possible benefits, and risks. After obtaining informed consent, the patients were included in the method of continuous sampling and convenient sampling. According to the method of random control, the patients were grouped. In the control group, the length of catheter insertion is measured from the pre-puncture point to the shoulder or armpit. In experimental group 1, the catheter insertion length is measured from the pre-puncture point to the midpoint of the clavicle, and in the experimental group, 2 catheter insertion length is measured from the pre-puncture point to the sternoclavicular joint. With a single-blind design, patients do not know the enrollment situation. The catheter was inserted by a full-time specialist nurse of intravenous therapy under ultrasound guidance combined with the modified Seedinger technique. The catheter was inserted according to the length of different measurement methods in different groups. After the catheter was inserted, an X-ray examination was performed to determine the catheter tip position again. Data collection and follow-up observation will be conducted by researchers who have been uniformly trained. Record the baseline data of the patients in the group before catheterization, record the insertion status during catheterization, record the patient's catheter use and catheter sealing frequency every day during catheter placement, and evaluate catheter function and complications until extubation daily.

Interventions

DEVICEShu Bei Kang (China) Midline Catheters

The procedures ① evaluation and selection of blood vessels: select the puncture vein in the middle of the patient's upper arm, ② Skin disinfection and towel laying: take the supine position, extend the upper limb to be punctured 45 \ 90 °, disinfect the pre punctured upper limb with 75% alcohol and 5% povidone iodine. ③ Puncture vein: tie a tourniquet to fill the vein. Before puncture, use 0.2 \ 0.4 ml of 2% lidocaine for local anesthesia. Under the guidance of ultrasound, use the puncture needle in the improved sedinger assembly for puncture. After successful puncture, insert the guide wire. ④ Delivery and confirmation of catheter position: after successful puncture, insert the dilator catheter sheath assembly, withdraw the setinger guide wire, deliver the catheter, after catheter placement, flush and seal the catheter with normal saline, and fix the catheter with sterile dressing.

Sponsors

Sir Run Run Shaw Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Expected intravenous infusion time over 1 week In line with the indications for the use of medium-length catheters More than 18 years old Full consciousness Signed the study informed consent

Exclusion criteria

Source of infection at the catheter insertion site History of radiation therapy, history of thrombosis, history of trauma or vascular surgery at the site of catheterization Treatment requires input of irritating or hyperosmolar solutions Patients who need to be discharged with a catheter

Design outcomes

Primary

MeasureTime frameDescription
Rate of exudationthrough study completion, an average of 4 weeksThere is a slight yellow or clear liquid leakage from the catheter puncture site
Rate of Bleedingthrough study completion, an average of 4 weeksBloody fluid still leaks out of catheter puncture 48 hours after catheter insertion
Rate of Dislodgmentthrough study completion, an average of 4 weeksThe catheter slipped more than 3cm above the exposed length of the first tube placement
Rate of Phlebitisthrough study completion, an average of 4 weeksProlonged veins appear red, swollen, hot, and painful, with severe cord-like changes and indurations when touching. Mechanical phlebitis, infectious phlebitis, and thrombophlebitis are collected as phlebitis data
Rate of Catheter-related thrombosisthrough study completion, an average of 4 weeksThe PICC-related thrombosis in this study refers only to symptomatic thrombi, excluding asymptomatic thrombi. Catheter-related venous thrombosis was diagnosed by color Doppler ultrasound examination when the clinical manifestations were related symptoms such as swelling and pain in the upper arm of the catheterization side.
Rate of Occlusionthrough study completion, an average of 4 weeksAccording to the degree, it is divided into complete occlusion and incomplete occlusion. When there is resistance or difficulty in flushing the tube, poor blood withdrawal or even no blood return can indicate that the catheter is incompletely occlusion; if it is difficult to flush the tube and draw blood, it can indicate that the catheter is completely occlusion.
Rate of Catheter-Related Infectionthrough study completion, an average of 4 weeksIncluding local infection of the puncture site and catheter-related blood stream infection (Catheter-Related Blood stream Infection, CRBSI). Local infection refers to redness, swelling and pain around the puncture point, or even pus; Catheter-associated bloodstream infection: refers to patients with indwelling catheters who develop bacteremia and draw blood cultures through peripheral veins for at least one positive result, accompanied by fever (\> 380C), chills, or hypotension. Other clear sources of bloodstream infection.

Secondary

MeasureTime frameDescription
Endometrial conditions24 hours before intubation and after extubationUltrasound examination of the vascular intima before catheterization and within 24 hours after extubation was performed. No abnormality in the intimal smoothness was negative, and abnormalities in the intimal smoothness and hyperplasia were positive.
Dwell timethrough study completion, an average of 4 weeksTime from tube insertion to extubation, in days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026