Clinical trial NCT04601597: A Multicentre Pilot Study of Midline Catheter's Tip at a Different Position in Antimicrobial Therapy
Official title: Midline Catheter Tip Position and Catheter-Related Complications in Antimicrobial Therapy- A Multi-centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: Infection nursing
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Phlebitis
timeFrame: through study completion, an average of 4 weeks
measure: Rate of Catheter-related thrombosis
timeFrame: through study completion, an average of 4 weeks
measure: Rate of Occlusion
timeFrame: through study completion, an average of 4 weeks
measure: Rate of Catheter-Related Infection
timeFrame: through study completion, an average of 4 weeks
measure: Rate of Bleeding
timeFrame: through study completion, an average of 4 weeks
measure: Rate of Dislodgment
timeFrame: through study completion, an average of 4 weeks
measure: Rate of exudation
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
measure: Dwell time
timeFrame: through study completion, an average of 4 weeks
measure: Endometrial conditions
timeFrame: 24 hours before intubation and after extubation
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University
state: Fujiang
city: Suzhou
country: China
facility: Changshu first people's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Kunshan first people's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Liaoning Provincial People's Hospital
state: Liaoning
city: Hangzhou
country: China
facility: Zhejiang Second Hospital Affiliated to Medical College of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Runrun Shaw Hospital
state: Zhejiang
Study officials:
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