Patients Requiring Peripherally Inserted Central Venous CathetersNCT05555160
Application of Intracavity Electrocardiogram Positioning Technique in PICC
A study testing PICC in people with Patients Requiring Peripherally Inserted Central Venous Catheters, run by Shandong Branden Med.Device Co.,Ltd.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients Requiring Peripherally Inserted Central Venous Catheters
- 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
- 3,051 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
- Being tested
- PICC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICCDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Single-chamber valve tip conductive PICC catheter | Experimental | Not described Receives: Device: PICC |
| Single - chamber valve non - tip conductive PICC catheter | Experimental | Not described Receives: Device: PICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after surgery
Secondary outcomes (6)
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.
Measured: 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.
Measured: Immediately after surgery
rate of convenient
survey whether the operators think the operation is convenient through questionnaires made by ourselves.
Measured: Immediately after surgery
rate of unplanned extubation
Proportion of early removal due to complications
Measured: After the operation to 180 days
Retention duration
Measured: After the operation to 180 days
Medical costs resulting from complications
Measured: After the operation to 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start30 Sep 2022 (estimated)
- Primary completion31 Dec 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 Patients Requiring Peripherally Inserted Central Venous CathetersStudies 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
- 3,051 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Branden Med.Device Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555160
- Sponsor's protocol ID
- B-202103
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Intracavity Electrocardiogram Positioning Technique in Catheterization of Valvular PICC
- ClinicalTrials.gov ID
- NCT05555160
- Acronym / sponsor ID
- B-202103
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,051 participants (estimated)
- Lead sponsor
- Shandong Branden Med.Device Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Sep 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-chamber valve tip conductive PICC catheter | Experimental | Device: PICC |
| Single - chamber valve non - tip conductive PICC catheter | Experimental | Device: PICC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| PICCPeripheral 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 | Device | Single - chamber valve non - tip conductive PICC catheter, Single-chamber valve tip conductive PICC catheter |
Primary outcome
Accuracy of tip determination
Time frame: Immediately after surgery
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.
6 secondary outcomes
incidence of PICC-related complications
Time frame: After the operation to 180 days
success rate of one catheterization
Time frame: Immediately after surgery
rate of convenient
Time frame: Immediately after surgery
rate of unplanned extubation
Time frame: After the operation to 180 days
Retention duration
Time frame: After the operation to 180 days
Medical costs resulting from complications
Time frame: After the operation to 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Undecided
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 Patients Requiring Peripherally Inserted Central Venous Catheters, 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 4 inclusion and 11 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 26 Sep 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?
Accuracy of tip determination (time frame: Immediately after surgery). 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 26 Sep 2022.