the Incidence of PICC-related Complications
Conditions
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
Interventions
DEVICEPICC
Tunnel PICC puncture technology is a perfect combination of ultrasound-guided puncture, ECG lead technology, PICC and subcutaneous tunnel. The valve conduction PICC is equipped with an integrated ECG lead Doppler ultrasound machine. Before the catheter is placed, in the yellow area, in the ultrasound mode, evaluate the blood vessel condition, measure the blood flow velocity, and correctly select the puncture site. When the catheter is pushed close to the superior vena cava, the electrocardiograph mode is switched to complete the precise positioning of the catheter according to the principle of ECG positioning technology. A subcutaneous tunnel was prepared in the green area, and the PICC at the puncture site in the yellow area was introduced to the green area and carefully bandaged. Whole-process integrated operation, simple and efficient operation.
Sponsors
Wuhan University
Enshi Clinical College of Wuhan University
Jingzhou Central Hospital
The Central Hospital of Huanggang
Hubei Cancer Hospital
Yichang Central People's Hospital
Sinopharm Gezhouba Group Central Hospital
Central Hospital of Xiaogan
Xiaogan First People's Hospital
Wuhan Central Hospital
Xiangyang Central Hospital
Xiangyang No.1 People's Hospital
Shandong Branden Med.Device Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| time of catheter indwelling | Intraoperative (Time from successful catheter insertion to extubation) | Time from successful catheter insertion to extubation |
| score of operation convenience | one hour | — |
| score of patient comfort | one hour | — |
| operation time | one hour | — |
Outcome results
None listed