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Application of Intracavity Electrocardiogram Positioning Technique in PICC

S

Shandong Branden Med.Device

Status

Unknown

Conditions

Patients Requiring Peripherally Inserted Central Venous Catheters

Treatments

Device: PICC

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05555160
B-202103

Details and patient eligibility

About

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.

Enrollment

3,051 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

3,051 participants in 2 patient groups

Single-chamber valve tip conductive PICC catheter
Experimental group
Treatment:
Device: PICC
Single - chamber valve non - tip conductive PICC catheter
Experimental group
Treatment:
Device: PICC

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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