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

February 20, 2023 updated by: Yong Fang, Sir Run Run Shaw Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujiang
      • Xiamen, Fujiang, China
        • Zhongshan Hospital Affiliated to Xiamen University
    • Jiangsu
      • Suzhou, Jiangsu, China
        • Changshu first people's Hospital
      • Suzhou, Jiangsu, China
        • Kunshan First People's Hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • Liaoning Provincial People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 31000
        • Zhejiang Second Hospital Affiliated to Medical College of Zhejiang University
      • Hangzhou, Zhejiang, China, 310016
        • Sir Runrun Shaw Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Study Population

Infected patients, neurosurgery, respiratory, gastroenterology, orthopedics, cardiology, general surgery and other inpatients in 6 general hospitals in china

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The catheter tip was placed in the subclavian vein.
The pre-placement catheter length measured through the body surface was greater than the actual length. Therefore, 2 cm was subtracted from the pre-puncture point to the ipsilateral sternoclavicular joint to calculate the effective catheter pre-placement length.
Device: Shu 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.
Experimental: The tip of the catheter was placed in the axillary vein of the chest wall.
The pre-placement length of the catheter was measured by subtracting 3-4 cm from the distance between the puncture point and ipsilateral midclavicular line. This adjustment was intended to prevent the catheter tip from entering the subclavian vein.
Device: Shu 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.
Experimental: the catheter tip was located distal to the axillary vein.
The measurement method of catheter pre-placement length was as follows: in cases where the catheter was punctured from the basilic and brachial veins, the distance from the pre-puncture point to the intermuscular sulcus of the ipsilateral deltoid muscle and pectoralis major muscle was measured (not surpassing the intermuscular sulcus and not reaching the axilla); however, the distance from the pre-puncture point to the ipsilateral sub shoulder or axilla was measured.
Device: Shu 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Phlebitis
Time Frame: through study completion, an average of 4 weeks
Prolonged 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
through study completion, an average of 4 weeks
Rate of Catheter-related thrombosis
Time Frame: through study completion, an average of 4 weeks
The 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.
through study completion, an average of 4 weeks
Rate of Occlusion
Time Frame: through study completion, an average of 4 weeks
According 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.
through study completion, an average of 4 weeks
Rate of Catheter-Related Infection
Time Frame: through study completion, an average of 4 weeks
Including 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.
through study completion, an average of 4 weeks
Rate of Bleeding
Time Frame: through study completion, an average of 4 weeks
Bloody fluid still leaks out of catheter puncture 48 hours after catheter insertion
through study completion, an average of 4 weeks
Rate of Dislodgment
Time Frame: through study completion, an average of 4 weeks
The catheter slipped more than 3cm above the exposed length of the first tube placement
through study completion, an average of 4 weeks
Rate of exudation
Time Frame: through study completion, an average of 4 weeks
There is a slight yellow or clear liquid leakage from the catheter puncture site
through study completion, an average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial conditions
Time Frame: 24 hours before intubation and after extubation
Ultrasound 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.
24 hours before intubation and after extubation
Dwell time
Time Frame: through study completion, an average of 4 weeks
Time from tube insertion to extubation, in days
through study completion, an average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2020

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 26, 2020

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVTEAM2020-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe