Comparing the Safety and Effectiveness of Tunnel PICC Guided by EDUG and Conventional PICC

Shandong Branden Med.Device

Status

Not yet enrolling

Conditions

the Incidence of PICC-related Complications

Treatments

Device: PICC

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05621473

brandentech-001

Details and patient eligibility

About

This study was designed as a prospective, multicenter, randomized controlled study, with the incidence of postoperative complications as the main observation end point. It was a superiority design.The purpose of this study was to compare the incidence of complications associated with EDUG-guided subcutaneous tunneling and conventional puncture after peripheral vein placement of PICCs

Enrollment

420 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥18 years old;
Immunocompromised patients, including:

① Patients with congenital T cell/B cell deficiency or macrophage disorder;

② Patients with solid malignant tumors or hematological malignancies;

③ Patients with AIDS;

④ Patients undergoing splenectomy or solid organ transplantation;

⑤ Patients with rheumatic diseases and treated with immunomodulatory drugs;
Follow the doctor's advice to perform PICC catheterization for the first time;
No serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease, severe conduction block, etc., before catheter placement;
Patients who have not participated in other clinical studies;
Patients who voluntarily participate in the clinical study and can cooperate with the clinical follow-up.

Exclusion criteria

Known allergy to catheter material;
History of infection, injury or radiation therapy at the puncture site;
There is a history of venous thrombosis or surgical operation at the puncture site;
Severe abnormal coagulation function;
Superior vena cava compression syndrome;
Radical mastectomy for breast cancer or axillary lymph node dissection on the operative side of the limb;
Pacemaker and arteriovenous fistula ipsilateral limb.