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NCT05555160 | Unknown status | Patients Requiring Peripherally Inserted Central Venous Catheters


Application of Intracavity Electrocardiogram Positioning Technique in PICC
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.

Condition or disease

Patients Requiring Peripherally Inserted Central Venous Catheters

Intervention/treatment

PICC

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 3051 participants
Masking: Single
Primary Purpose: Treatment
Official Title: Application of Intracavity Electrocardiogram Positioning Technique in Catheterization of Valvular PICC
Actual Study Start Date : September 30, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Arm Intervention/treatment

Experimental: Single-chamber valve tip conductive PICC catheter

Device: PICC

Experimental: Single - chamber valve non - tip conductive PICC catheter

Device: PICC

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Application of Intracavity Electrocardiogram Positioning Technique in PICC

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Application of Intracavity Electrocardiogram Positioning Technique in PICC

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