Application of Intracavity Electrocardiogram Positioning Technique in PICC

NCT ID: NCT05555160

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3051 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-12-31

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.

Conditions

Patients Requiring Peripherally Inserted Central Venous Catheters

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single-chamber valve tip conductive PICC catheter

Group Type: EXPERIMENTAL

PICC

Intervention Type: DEVICE

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

Single - chamber valve non - tip conductive PICC catheter

Group Type: EXPERIMENTAL

PICC

Intervention Type: DEVICE

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

Interventions

PICC

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Shandong Branden Med.Device Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

B-202103

Identifier Type: -

Identifier Source: org_study_id