Comparing the Safety and Efficacy of EDUG-guided Tunnel PICC With Conventional PICC in Immunocompromised Patients: a Multicenter, Prospective, Randomized Controlled Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 420
- Primary Endpoint
- rate of PICC-related complications
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
rate of PICC-related complications
Time Frame: 6 months after operation
Observe and record the incidence of catheter-related complications during catheter placement, such as bleeding, subcutaneous congestion, lymphatic exudation, phlebitis (bacterial phlebitis, mechanical phlebitis, thrombophlebitis), infection (local infection, tunneling) Infection, catheter-related bloodstream infection), thrombosis (symptomatic thrombosis, asymptomatic thrombosis), catheter ectopic, medical adhesive-related skin injury, catheter injury and blockage, etc.
Secondary Outcomes
- rate of unplanned extubation(through study completion, an average of 4months)
- success rate of one-time catheter placement(one hour)
- score of patient comfort(one hour)
- score of operation convenience(one hour)
- operation time(one hour)
- time of catheter indwelling(Intraoperative (Time from successful catheter insertion to extubation))