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

Comparing the Safety and Efficacy of EDUG-guided Tunnel PICC With Conventional PICC in Immunocompromised Patients: a Multicenter, Prospective, Randomized Controlled Clinical Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: the Incidence of PICC-related Complications
• Intervention / Treatment: Device: PICC

• Study Type: Interventional
• Enrollment (Anticipated): 420
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trial group; This arm of patients received tunnel PICC interventions	Device: 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.; Other Names: Peripherally inserted central venous catheter
Experimental: control group; This arm of patients received normal PICC interventions	Device: 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.; Other Names: Peripherally inserted central venous catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of catheter indwelling	Time from successful catheter insertion to extubation	Intraoperative (Time from successful catheter insertion to extubation)
rate of unplanned extubation	the incidence 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
score of patient comfort		one hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: brandentech-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No