CancerPICCNCT05870449
The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications
A study testing tunneled PICC and routine PICC in people with Cancer and Thrombus, run by Shandong Branden Med.Device Co.,Ltd.
Trial summary
In this study, eligible subjects were randomly assigned to the experimental or control group through randomization (1:1). Under the guidance of electrocardiographic Doppler ultrasound guided puncture and catheterization (EDUG) technology, the tunnel puncture method was compared with the conventional puncture method. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- tunneled PICC and routine PICC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,666 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 31 Dec 2024
- 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
- Patients aged ≥ 18 years old;
- Patients who follow medical advice and require PICC catheterization;
- Patients who have not participated in other clinical studies;
- Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up;
- There are no serious cardiovascular diseases, such as atrial fibrillation, pulmonary heart disease, and other P-wave abnormalities before catheterization, as well as severe heart conduction block
Who cannot join
- Known allergies to catheter materials;
- There is a history of infection, injury, and radiation therapy at the puncture site;
- The puncture site has a history of venous thrombosis or surgery;
- Severe abnormal coagulation function;
- Superior vena cava compression syndrome;
- Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
- Heart pacemaker and arteriovenous fistula on the same side of the limb;
- Patients or patients' family members refuse to sign the informed consent form.
About this study
Official title: The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications and Intervention Measures - Prospective, Multicenter, Randomized Controlled Study
In this study, eligible subjects were randomly assigned to the experimental or control group through randomization (1:1). Under the guidance of electrocardiographic Doppler ultrasound guided puncture and catheterization (EDUG) technology, the tunnel puncture method was compared with the conventional puncture method. The two groups of patients were observed and evaluated intraoperative and postoperative 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, and 90 ± 10 days 120 ± 10 days (if any) and the occurrence of complications during extubation or unplanned extubation at the end of treatment, comparing cases in the north and south, as well as complications related to different catheterization methods
- Conditions
- Cancer, Thrombus, Phlebitis, Infections
- Being tested
- tunneled PICC, routine PICC
- Medical subject headings
- Neoplasms, Thrombosis, Phlebitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunneled PICCDevice
Tunneled PICC is a type of PICC catheterization technique that involves establishing a subcutaneous tunnel to keep the outlet of the catheter away from the puncture site
routine PICCDevice
Peripherally inserted central venous catheterization is a technique that involves inserting PICC through the peripheral vein and infusing drugs into the central vein through a catheter.
| Study group | Role | What they receive |
|---|---|---|
| trial group | Experimental | Not described Receives: Device: tunneled PICC |
| control group | Active comparator | Not described Receives: Device: routine PICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of complications
Measured: 120 days after operation
Secondary outcomes (1)
time of catheter retention
Measured: 7, 30, 60, 90 and 120 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 1,666 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Branden Med.Device Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hainan Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870449
- Sponsor's protocol ID
- hainan-01
- Acronym
- PICC
- Status last verified
- May 2023
- First submitted
- 6 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications and Intervention Measures - Prospective, Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05870449
- Acronym / sponsor ID
- PICC / hainan-01
- Conditions
- Cancer, Thrombus, Phlebitis, Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,666 participants (estimated)
- Lead sponsor
- Shandong Branden Med.Device Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hainan Cancer Hospital
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 May 2023 (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.
In this study, eligible subjects were randomly assigned to the experimental or control group through randomization (1:1). Under the guidance of electrocardiographic Doppler ultrasound guided puncture and catheterization (EDUG) technology, the tunnel puncture method was compared with the conventional puncture method. The two groups of patients were observed and evaluated intraoperative and postoperative 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, and 90 ± 10 days 120 ± 10 days (if any) and the occurrence of complications during extubation or unplanned extubation at the end of treatment, comparing cases in the north and south, as well as complications related to different catheterization methods
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: tunneled PICC |
| control group | Active comparator | Device: routine PICC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged ≥ 18 years old;
- Patients who follow medical advice and require PICC catheterization;
- Patients who have not participated in other clinical studies;
- Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up;
- There are no serious cardiovascular diseases, such as atrial fibrillation, pulmonary heart disease, and other P-wave abnormalities before catheterization, as well as severe heart conduction block
Key exclusion criteria (8 listed)
- Known allergies to catheter materials;
- There is a history of infection, injury, and radiation therapy at the puncture site;
- The puncture site has a history of venous thrombosis or surgery;
- 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 |
|---|---|---|
| tunneled PICCTunneled PICC is a type of PICC catheterization technique that involves establishing a subcutaneous tunnel to keep the outlet of the catheter away from the puncture site | Device | trial group |
| routine PICCPeripherally inserted central venous catheterization is a technique that involves inserting PICC through the peripheral vein and infusing drugs into the central vein through a catheter. | Device | control group |
Primary outcome
rate of complications
Time frame: 120 days after operation
1 secondary outcome
time of catheter retention
Time frame: 7, 30, 60, 90 and 120 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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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 tunneled PICC and routine PICC in people with Cancer and Thrombus, 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 5 inclusion and 8 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 23 May 2023. 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 complications (time frame: 120 days 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 23 May 2023.