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The Effect of Skin Laxity on the PICC

F

First People's Hospital of Foshan

Status

Not yet enrolling

Conditions

Complications; Catheter

Treatments

Device: tunneled PICC

Study type

Interventional

Funder types

Other

Identifiers

NCT05629195
foshan202271

Details and patient eligibility

About

To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients (tunneled PICC vs conventional PICC).

Full description

In this study, tunneled PICC was compared with conventional PICC. Eligible subjects were randomly enrolled into the test group or control group by randomization (1:1), and observed and evaluated the occurrence of complications during and 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, 90 ± 10 days, 120 ± 10 days (if any) after surgery and extubation at the end of treatment. To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients

Enrollment

356 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients ≥ 18 years old;
  • Patients who need PICC catheterization according to the doctor's advice;
  • There is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for PICC catheterization;
  • There is no serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease and other patients with abnormal P wave, and severe heart block before 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

Exclusion criteria

  • Known allergy to catheter material;
  • The puncture site has a history of infection, injury and radiotherapy;
  • The puncture site has a history of venous thrombosis or surgery;
  • Severe abnormal bleeding and coagulation function;
  • Superior vena cava compression syndrome;
  • Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
  • The ipsilateral limb of the pacemaker and the arteriovenous fistula;
  • patient or her/his family members refuse to sign the informed consent form.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

356 participants in 2 patient groups

tunneled PICC
Experimental group
Description:
Placement of PICC catheter through tunnel technology
Treatment:
Device: tunneled PICC
conventional PICC
Active Comparator group
Description:
Placement of PICC catheter through conventional technology
Treatment:
Device: tunneled PICC

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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