Comparing the Safety and Effectiveness of Tunnel PICC Guided by EDUG and Conventional PICC

NCT ID: NCT05621473

Last Updated: 2022-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-12-31

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

Conditions

the Incidence of PICC-related Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

trial group

This arm of patients received tunnel PICC interventions

Group Type: EXPERIMENTAL

PICC

Intervention Type: DEVICE

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.

control group

This arm of patients received normal PICC interventions

Group Type: EXPERIMENTAL

PICC

Intervention Type: DEVICE

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.

Interventions

PICC

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.

Intervention Type: DEVICE

Other Intervention Names

Peripherally inserted central venous catheter

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wuhan University

OTHER

Sponsor Role: collaborator

Enshi Clinical College of Wuhan University

UNKNOWN

Sponsor Role: collaborator

Jingzhou Central Hospital

OTHER

Sponsor Role: collaborator

The Central Hospital of Huanggang

OTHER

Sponsor Role: collaborator

Hubei Cancer Hospital

OTHER

Sponsor Role: collaborator

Yichang Central People's Hospital

OTHER

Sponsor Role: collaborator

Sinopharm Gezhouba Group Central Hospital

UNKNOWN

Sponsor Role: collaborator

Central Hospital of Xiaogan

OTHER

Sponsor Role: collaborator

Xiaogan First People's Hospital

UNKNOWN

Sponsor Role: collaborator

Wuhan Central Hospital

OTHER

Sponsor Role: collaborator

Xiangyang Central Hospital

OTHER

Sponsor Role: collaborator

Xiangyang No.1 People's Hospital

OTHER

Sponsor Role: collaborator

Shandong Branden Med.Device Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

brandentech-001

Identifier Type: -

Identifier Source: org_study_id