Application of Intracavity Electrocardiogram Positioning Technique in PICC

Shandong Branden Med.Device Co.,Ltd3,051 enrolled

Overview

This study was a prospective, multicenter, randomized controlled study. The study aimed to exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on the positioning accuracy of catheter tip and exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on catheterization complications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,051

Conditions

Patients Requiring Peripherally Inserted Central Venous Catheters

Interventions

PICCDEVICE

Peripheral central venous catheterization (PICC) is mainly applied to patients with medium and long-term intravenous infusion, infusion of stimulant drugs and intermittent infusion of chemotherapy drugs. It is a catheterization technology to place PICC through peripheral veins and make its tip reach the central vein

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients ≥18 years old who need PICC catheterization for the first time according to the doctor's advice; * No serious cardiovascular diseases before catheterization, such as atrial fibrillation, pulmonary heart disease and other P wave abnormalities, serious heart block, etc.; * patients who did not participate in other clinical studies; * Patients who voluntarily participated in the clinical study, signed informed consent and cooperated with clinical follow-up Exclusion Criteria: * patients with local malformation or scar formation; * Patients with infection or damage at the puncture site; * patients with tumor compression of blood vessels; * Patients with confirmed or suspected catheter-related infection, bacteremia and septicemia * Patients diagnosed or suspected to be allergic to silicone material * Patients with a history of radiotherapy at the pre-intubation site * Patients with a history of venous thrombosis, trauma or vascular surgery * Patients with superior vena cava syndrome * Patients with poor medical behavior * Patients with severe peripheral vascular edema * High-flow fluid infusion, patients requiring hemodialysis, pacemaker installation, crutches, or patients who may undergo A-V fistula

Outcomes

Primary Outcomes

Accuracy of tip determination

IC-ECG method was used to place the tube, and X-ray was used to determine the accuracy of tip location after confirmation. If the two judgments are inconsistent, the third method, such as echocardiography, shall be used. The tip determination accuracy of IC-ECG localization method and X-ray localization method were calculated respectively.X-ray judgment standard: the reference standard is the first choice of the cardiac shadow method: not exceeding the highest protrusion on the left side of the cardiac shadow (tracheal protrusion method: 0-3cm below the tracheal protrusion); Secondary rib reading method: posterior 5-7 ribs.

Time frame: Immediately after surgery

Secondary Outcomes

incidence of PICC-related complications

Complications related to puncture and catheter during tube placement and retention include redness and swelling, bleeding, exudation, puncture point infection, ectopic catheter, displacement, catheter blockage, rupture, phlebitis and thrombosis.

Time frame: After the operation to 180 days

success rate of one catheterization

one-time successful catheterization means that the tip of the catheter can be placed at the ideal position in one catheterization operation, without adjustment after X-ray confirmation. After catheterization, both groups of patients need to verify whether the tip is in the ideal position through X-ray, and whether the operation is successful also needs to be judged through X-ray, and the X-ray results need to be retained (random number, center code, initials, time). All results will be sent to the central laboratory for analysis and interpretation.

Time frame: Immediately after surgery

rate of convenient

survey whether the operators think the operation is convenient through questionnaires made by ourselves.

Time frame: Immediately after surgery

rate of unplanned extubation

Data from ClinicalTrials.gov

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