Comparing the Safety and Effectiveness of Tunnel PICC Guided by EDUG and Conventional PICC
- Conditions
- the Incidence of PICC-related Complications
- Interventions
- Device: PICC
- Registration Number
- NCT05621473
- Lead Sponsor
- Shandong Branden Med.Device Co.,Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 420
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description trial group PICC This arm of patients received tunnel PICC interventions control group PICC This arm of patients received normal PICC interventions
- Primary Outcome Measures
Name Time Method rate of PICC-related complications 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 Outcome Measures
Name Time Method rate of unplanned extubation through study completion, an average of 4months the incidence of unplanned extubation
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) Time from successful catheter insertion to extubation