the Incidence of PICC-related ComplicationsPICCNCT05621473
Comparing the Safety and Effectiveness of Tunnel PICC Guided by EDUG and Conventional PICC
A study testing PICC in people with the Incidence of PICC-related Complications, run by Shandong Branden Med.Device Co.,Ltd.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Incidence of PICC-related Complications
- What is being tested?
- PICC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
About this study
Official title: 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
- Being tested
- PICC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICCDevice
Also called Peripherally inserted central venous catheter
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.
| Study group | Role | What they receive |
|---|---|---|
| trial group | Experimental | This arm of patients received tunnel PICC interventions Receives: Device: PICC |
| control group | Experimental | This arm of patients received normal PICC interventions Receives: Device: PICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after operation
Secondary outcomes (6)
time of catheter indwelling
Time from successful catheter insertion to extubation
Measured: Intraoperative (Time from successful catheter insertion to extubation)
rate of unplanned extubation
the incidence of unplanned extubation
Measured: through study completion, an average of 4months
success rate of one-time catheter placement
Measured: one hour
operation time
Measured: one hour
score of operation convenience
Measured: one hour
score of patient comfort
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Incidence of PICC-related ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Branden Med.Device Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wuhan University, Enshi Clinical College of Wuhan University, Jingzhou Central Hospital, The Central Hospital of Huanggang, Hubei Cancer Hospital, Yichang Central People's Hospital, Sinopharm Gezhouba Group Central Hospital, Central Hospital of Xiaogan, Xiaogan First People's Hospital, Wuhan Central Hospital, Xiangyang Central Hospital, Xiangyang No.1 People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621473
- Sponsor's protocol ID
- brandentech-001
- Acronym
- PICC
- Status last verified
- Nov 2022
- First submitted
- 26 Sep 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Safety and Efficacy of EDUG-guided Tunnel PICC With Conventional PICC in Immunocompromised Patients: a Multicenter, Prospective, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05621473
- Acronym / sponsor ID
- PICC / brandentech-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Shandong Branden Med.Device Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Wuhan University, Enshi Clinical College of Wuhan University, Jingzhou Central Hospital, The Central Hospital of Huanggang, Hubei Cancer Hospital, Yichang Central People's Hospital, Sinopharm Gezhouba Group Central Hospital, Central Hospital of Xiaogan, Xiaogan First People's Hospital, Wuhan Central Hospital, Xiangyang Central Hospital, Xiangyang No.1 People's Hospital
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | Experimental | Device: PICCThis arm of patients received tunnel PICC interventions |
| control group | Experimental | Device: PICCThis arm of patients received normal PICC interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICCAlso: Peripherally inserted central venous catheterTunnel 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. | Device | control group, trial group |
Primary outcome
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 secondary outcomes
time of catheter indwelling
Time frame: Intraoperative (Time from successful catheter insertion to extubation)
rate of unplanned extubation
Time frame: through study completion, an average of 4months
success rate of one-time catheter placement
Time frame: one hour
operation time
Time frame: one hour
score of operation convenience
Time frame: one hour
score of patient comfort
Time frame: one hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PICC in people with the Incidence of PICC-related Complications, run by Shandong Branden Med.Device Co.,Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of PICC-related complications (time frame: 6 months after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.