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

November 17, 2022 updated by: Shandong Branden Med.Device Co.,Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
rate of PICC-related complications
Time Frame: 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.
6 months after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
time of catheter indwelling
Time Frame: Intraoperative (Time from successful catheter insertion to extubation)
Time from successful catheter insertion to extubation
Intraoperative (Time from successful catheter insertion to extubation)
rate of unplanned extubation
Time Frame: through study completion, an average of 4months
the incidence of unplanned extubation
through study completion, an average of 4months
success rate of one-time catheter placement
Time Frame: one hour
one hour
operation time
Time Frame: one hour
one hour
score of operation convenience
Time Frame: one hour
one hour
score of patient comfort
Time Frame: one hour
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Branden Med.Device Co.,Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings