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

Zhejiang University

Status: Completed

Conditions: Infection

Treatments: Device: Shu Bei Kang (China) Midline Catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT04601597

IVTEAM2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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330 participants in 3 patient groups

The catheter tip was placed in the subclavian vein.

Experimental group

Description:

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.

Treatment:

Device: Shu Bei Kang (China) Midline Catheters

The tip of the catheter was placed in the axillary vein of the chest wall.

Experimental group

Description:

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.

Treatment:

Device: Shu Bei Kang (China) Midline Catheters

the catheter tip was located distal to the axillary vein.

Experimental group

Description:

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.

Treatment:

Device: Shu Bei Kang (China) Midline Catheters