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

NCT05621473 | Unknown

• 1 other identifier: brandentech-001
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• rate of PICC-related complications

  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.

  6 months after operation

Secondary Outcomes (6)

• time of catheter indwelling

  Intraoperative (Time from successful catheter insertion to extubation)

• rate of unplanned extubation

  through study completion, an average of 4months

• success rate of one-time catheter placement

  one hour

• operation time

  one hour

• score of operation convenience

  one hour

Study Arms (2)

trial group

EXPERIMENTAL

This arm of patients received tunnel PICC interventions

Device: PICC

control group

EXPERIMENTAL

This arm of patients received normal PICC interventions

Device: PICC

Interventions

PICC 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.

Also known as: Peripherally inserted central venous catheter

control group; trial group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead
• Wuhan University: collaborator
• Enshi Clinical College of Wuhan University: collaborator
• Jingzhou Central Hospital: collaborator
• The Central Hospital of Huanggang: collaborator
• Hubei Cancer Hospital: collaborator
• Yichang Central People's Hospital: collaborator
• Sinopharm Gezhouba Group Central Hospital: collaborator
• Central Hospital of Xiaogan: collaborator
• Xiaogan First People's Hospital: collaborator
• Wuhan Central Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• Xiangyang No.1 People's Hospital: collaborator

MeSH Terms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: November 18, 2022
• Study Start: December 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 18, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share