Clinical trial NCT05621473: Comparing the Safety and Effectiveness of Tunnel PICC Guided by EDUG and Conventional PICC
Official title: Comparing the Safety and Efficacy of EDUG-guided Tunnel PICC With Conventional PICC in Immunocompromised Patients: a Multicenter, Prospective, Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: the Incidence of PICC-related Complications
Lead sponsor: Shandong Branden Med.Device Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Wuhan University
name: Enshi Clinical College of Wuhan University
name: Jingzhou Central Hospital
name: The Central Hospital of Huanggang
name: Hubei Cancer Hospital
name: Yichang Central People's Hospital
name: Sinopharm Gezhouba Group Central Hospital
name: Central Hospital of Xiaogan
name: Xiaogan First People's Hospital
name: Wuhan Central Hospital
name: Xiangyang Central Hospital
name: Xiangyang No.1 People's Hospital
First posted: 2022-11-18
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: rate of PICC-related complications
timeFrame: 6 months after operation
Secondary outcomes:
measure: time of catheter indwelling
timeFrame: Intraoperative (Time from successful catheter insertion to extubation)
measure: rate of unplanned extubation
timeFrame: through study completion, an average of 4months
measure: success rate of one-time catheter placement
timeFrame: one hour
measure: operation time
timeFrame: one hour
measure: score of operation convenience
timeFrame: one hour
measure: score of patient comfort
timeFrame: one hour
Other outcomes:
Locations:
Study officials:
References: