Complications; CatheterPICCNCT05629195
The Effect of Skin Laxity on the PICC
A study testing tunneled PICC in people with Complications; Catheter, run by First People's Hospital of Foshan.
Trial summary
To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients (tunneled PICC vs conventional PICC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications; Catheter
- What is being tested?
- tunneled PICC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 30 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
- Patients ≥ 18 years old;
- Patients who need PICC catheterization according to the doctor's advice;
- There is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for PICC catheterization;
- There is no serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease and other patients with abnormal P wave, and severe heart block before 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
Who cannot join
- Known allergy to catheter material;
- The puncture site has a history of infection, injury and radiotherapy;
- The puncture site has a history of venous thrombosis or surgery;
- Severe abnormal bleeding and coagulation function;
- Superior vena cava compression syndrome;
- Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
- The ipsilateral limb of the pacemaker and the arteriovenous fistula;
- patient or her/his family members refuse to sign the informed consent form.
About this study
Official title: Study on the Influence of Skin Laxity on the Application Effect of Different PICC Catheterization Methods
To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients (tunneled PICC vs conventional PICC).
Read the detailed description
In this study, tunneled PICC was compared with conventional PICC. Eligible subjects were randomly enrolled into the test group or control group by randomization (1:1), and observed and evaluated the occurrence of complications during and 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, 90 ± 10 days, 120 ± 10 days (if any) after surgery and extubation at the end of treatment. To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients
- Conditions
- Complications; Catheter
- Being tested
- tunneled PICC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunneled PICCDevice
PICC catheter is inserted into the superior vena cava through the upper brachial vein by establishing a subcutaneous tunnel
| Study group | Role | What they receive |
|---|---|---|
| tunneled PICC | Experimental | Placement of PICC catheter through tunnel technology Receives: Device: tunneled PICC |
| conventional PICC | Active comparator | Placement of PICC catheter through conventional technology Receives: Device: tunneled PICC |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of PICC complications
Including bleeding, subcutaneous congestion, lymphatic exudation, phlebitis (mechanical phlebitis, thrombophlebitis), infection (local infection, tunnel infection, catheter related blood flow infection), thrombus (symptomatic thrombus, asymptomatic thrombus), catheter ectopic, medical adhesive related skin damage, catheter damage and blockage, etc
Measured: 120 days
Secondary outcomes (5)
time of PICC insertion
Time from the start of skin disinfection to the end of dressing fixation
Measured: 1 hour
Success rate of catheterization
Judgment of successful catheterization: The catheterization is successful and the catheter is placed in an accurate position, that is, the tip of the catheter reaches within 1/3 of the lower part of the superior vena cava or near the junction of the right atrium.
Measured: 1 hour
score of operation pain
Wong Banker facial expression scale was used. This method uses 6 facial expressions from smile to cry to express the degree of pain: 0 points for no pain, 1 point for slight pain, 2 points for some pain, 3 points for very pain, 4 points for severe pain, and 5 points for unbearable pain
Measured: 1 hour
rate of unplanned extubation
Extubation after abnormal treatment
Measured: 120 days
rate of difficulty in decannulation
Probability of failure to pull out PICC due to vasospasm, adhesion with thrombus, wrapping of fibrin sheath, etc
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; CatheterStudies 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
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Foshan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingshan Zheng, First People's Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629195
- Sponsor's protocol ID
- foshan202271
- Acronym
- PICC
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2022
- Last updated
- 29 Nov 2022
- 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 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Influence of Skin Laxity on the Application Effect of Different PICC Catheterization Methods
- ClinicalTrials.gov ID
- NCT05629195
- Acronym / sponsor ID
- PICC / foshan202271
- Conditions
- Complications; Catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- First People's Hospital of FoshanUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 29 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.
To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients (tunneled PICC vs conventional PICC).
Detailed description
In this study, tunneled PICC was compared with conventional PICC. Eligible subjects were randomly enrolled into the test group or control group by randomization (1:1), and observed and evaluated the occurrence of complications during and 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, 90 ± 10 days, 120 ± 10 days (if any) after surgery and extubation at the end of treatment. To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tunneled PICC | Experimental | Device: tunneled PICCPlacement of PICC catheter through tunnel technology |
| conventional PICC | Active comparator | Device: tunneled PICCPlacement of PICC catheter through conventional technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 18 years old;
- Patients who need PICC catheterization according to the doctor's advice;
- There is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for PICC catheterization;
- There is no serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease and other patients with abnormal P wave, and severe heart block before catheterization
- Patients who have not participated in other clinical studies;
Key exclusion criteria (8 listed)
- Known allergy to catheter material;
- The puncture site has a history of infection, injury and radiotherapy;
- The puncture site has a history of venous thrombosis or surgery;
- Severe abnormal bleeding and 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 PICCPICC catheter is inserted into the superior vena cava through the upper brachial vein by establishing a subcutaneous tunnel | Device | conventional PICC, tunneled PICC |
Primary outcome
rate of PICC complications
Time frame: 120 days
Including bleeding, subcutaneous congestion, lymphatic exudation, phlebitis (mechanical phlebitis, thrombophlebitis), infection (local infection, tunnel infection, catheter related blood flow infection), thrombus (symptomatic thrombus, asymptomatic thrombus), catheter ectopic, medical adhesive related skin damage, catheter damage and blockage, etc
5 secondary outcomes
time of PICC insertion
Time frame: 1 hour
Success rate of catheterization
Time frame: 1 hour
score of operation pain
Time frame: 1 hour
rate of unplanned extubation
Time frame: 120 days
rate of difficulty in decannulation
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
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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 in people with Complications; Catheter, run by First People's Hospital of Foshan.
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 6 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 29 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 complications (time frame: 120 days). 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 29 Nov 2022.