Comparing the Safety and Effectiveness of Tunnel PICC Guided by EDUG and Conventional PICC (NCT05621473) | Clinical Trial Compass
UnknownNot Applicable
Comparing the Safety and Effectiveness of Tunnel PICC Guided by EDUG and Conventional PICC
420 participantsStarted 2022-12-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.