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The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications

S

Shandong Branden Med.Device

Status

Not yet enrolling

Conditions

Phlebitis
Infections
Cancer
Thrombus

Treatments

Device: tunneled PICC
Device: routine PICC

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05870449
hainan-01

Details and patient eligibility

About

In this study, eligible subjects were randomly assigned to the experimental or control group through randomization (1:1). Under the guidance of electrocardiographic Doppler ultrasound guided puncture and catheterization (EDUG) technology, the tunnel puncture method was compared with the conventional puncture method. The two groups of patients were observed and evaluated intraoperative and postoperative 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, and 90 ± 10 days 120 ± 10 days (if any) and the occurrence of complications during extubation or unplanned extubation at the end of treatment, comparing cases in the north and south, as well as complications related to different catheterization methods

Enrollment

1,666 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged ≥ 18 years old;
  • Patients who follow medical advice and require PICC catheterization;
  • Patients who have not participated in other clinical studies;
  • Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up;
  • There are no serious cardiovascular diseases, such as atrial fibrillation, pulmonary heart disease, and other P-wave abnormalities before catheterization, as well as severe heart conduction block

Exclusion criteria

  • Known allergies to catheter materials;
  • There is a history of infection, injury, and radiation therapy at the puncture site;
  • The puncture site has a history of venous thrombosis or surgery;
  • Severe abnormal coagulation function;
  • Superior vena cava compression syndrome;
  • Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
  • Heart pacemaker and arteriovenous fistula on the same side of the limb;
  • Patients or patients' family members refuse to sign the informed consent form.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,666 participants in 2 patient groups

trial group
Experimental group
Treatment:
Device: tunneled PICC
control group
Active Comparator group
Treatment:
Device: routine PICC

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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