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NCT05621473
Comparing the Safety and Effectiveness of Tunnel PICC Guided by EDUG and Conventional PICC
Conditions: the Incidence of PICC-related Complications
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 420
Sponsor: Shandong Branden Med.Device Co.,Ltd
Summary
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
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05621473). StuddyBuddy aggregates publicly available trial information.