Application of Intracavity Electrocardiogram Positioning Technique in PICC

Not Applicable

• Conditions: Patients Requiring Peripherally Inserted Central Venous Catheters
• Interventions: Device: PICC

• Registration Number: NCT05555160
• Lead Sponsor: Shandong Branden Med.Device Co.,Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Study Start: 2022-09-30
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3051

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-chamber valve tip conductive PICC catheter	PICC	-
Single - chamber valve non - tip conductive PICC catheter	PICC	-

Primary Outcome Measures

Name	Time	Method
Accuracy of tip determination	Immediately after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Medical costs resulting from complications	After the operation to 180 days
rate of convenient	Immediately after surgery	survey whether the operators think the operation is convenient through questionnaires made by ourselves.
Retention duration	After the operation to 180 days
success rate of one catheterization	Immediately after surgery	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.
incidence of PICC-related complications	After the operation to 180 days	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.
rate of unplanned extubation	After the operation to 180 days	Proportion of early removal due to complications