Application of Intracavity Electrocardiogram Positioning Technique in PICC

Application of Intracavity Electrocardiogram Positioning Technique in Catheterization of Valvular PICC

This study was a prospective, multicenter, randomized controlled study. The study aimed to exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on the positioning accuracy of catheter tip and exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on catheterization complications.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients Requiring Peripherally Inserted Central Venous Catheters
• Intervention / Treatment: Device: PICC

• Study Type: Interventional
• Enrollment (Anticipated): 3051
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients ≥18 years old who need PICC catheterization for the first time according to the doctor's advice;
• No serious cardiovascular diseases before catheterization, such as atrial fibrillation, pulmonary heart disease and other P wave abnormalities, serious heart block, etc.;
• patients who did not participate in other clinical studies;
• Patients who voluntarily participated in the clinical study, signed informed consent and cooperated with clinical follow-up

Exclusion Criteria:

• patients with local malformation or scar formation;
• Patients with infection or damage at the puncture site;
• patients with tumor compression of blood vessels;
• Patients with confirmed or suspected catheter-related infection, bacteremia and septicemia
• Patients diagnosed or suspected to be allergic to silicone material
• Patients with a history of radiotherapy at the pre-intubation site
• Patients with a history of venous thrombosis, trauma or vascular surgery
• Patients with superior vena cava syndrome
• Patients with poor medical behavior
• Patients with severe peripheral vascular edema
• High-flow fluid infusion, patients requiring hemodialysis, pacemaker installation, crutches, or patients who may undergo A-V fistula

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single-chamber valve tip conductive PICC catheter	Device: PICC; Peripheral central venous catheterization (PICC) is mainly applied to patients with medium and long-term intravenous infusion, infusion of stimulant drugs and intermittent infusion of chemotherapy drugs. It is a catheterization technology to place PICC through peripheral veins and make its tip reach the central vein
EXPERIMENTAL: Single - chamber valve non - tip conductive PICC catheter	Device: PICC; Peripheral central venous catheterization (PICC) is mainly applied to patients with medium and long-term intravenous infusion, infusion of stimulant drugs and intermittent infusion of chemotherapy drugs. It is a catheterization technology to place PICC through peripheral veins and make its tip reach the central vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of tip determination	IC-ECG method was used to place the tube, and X-ray was used to determine the accuracy of tip location after confirmation. If the two judgments are inconsistent, the third method, such as echocardiography, shall be used. The tip determination accuracy of IC-ECG localization method and X-ray localization method were calculated respectively.X-ray judgment standard: the reference standard is the first choice of the cardiac shadow method: not exceeding the highest protrusion on the left side of the cardiac shadow (tracheal protrusion method: 0-3cm below the tracheal protrusion); Secondary rib reading method: posterior 5-7 ribs.	Immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of PICC-related complications	Complications related to puncture and catheter during tube placement and retention include redness and swelling, bleeding, exudation, puncture point infection, ectopic catheter, displacement, catheter blockage, rupture, phlebitis and thrombosis.	After the operation to 180 days
success rate of one catheterization	one-time successful catheterization means that the tip of the catheter can be placed at the ideal position in one catheterization operation, without adjustment after X-ray confirmation. After catheterization, both groups of patients need to verify whether the tip is in the ideal position through X-ray, and whether the operation is successful also needs to be judged through X-ray, and the X-ray results need to be retained (random number, center code, initials, time). All results will be sent to the central laboratory for analysis and interpretation.	Immediately after surgery
rate of convenient	survey whether the operators think the operation is convenient through questionnaires made by ourselves.	Immediately after surgery
rate of unplanned extubation	Proportion of early removal due to complications	After the operation to 180 days
Retention duration		After the operation to 180 days
Medical costs resulting from complications		After the operation to 180 days

Collaborators and Investigators

• Sponsor: Shandong Branden Med.Device Co.,Ltd
• Collaborators: Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 30, 2022
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (ACTUAL): September 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B-202103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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