PICC Line PlacementNCT07594704
Effects of Different Tunnel Methods in PICC Catheterization
A study testing One-needle tunnel technique and two-needle tunnel technique in people with PICC Line Placement and PICC-associated Thrombosis, run by Sun Yat-sen University at 1 site in China.
Trial summary
This prospective randomized controlled trial compares the effectiveness and safety of one-needle and two-needle tunneling techniques for peripherally inserted central catheter (PICC) placement, aiming to identify the optimal tunneling method to reduce catheter-related complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PICC Line Placement, PICC-associated Thrombosis
- What is being tested?
- One-needle tunnel technique and two-needle tunnel technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 years old;
- Educational level of primary school or above, with basic listening, speaking, reading and writing abilities, and capable of completing the questionnaire independently;
- Receiving tunneled PICC catheterization for the first time, with 4Fr single-lumen solo PICC catheter indwelling;
- Able to attend regular PICC maintenance at our hospital as scheduled after catheterization;
- Voluntarily participate in this study and sign the informed consent form for this study as well as the informed consent form for PICC catheterization.
Who cannot join
- Patients with coagulation dysfunction (INR > 1.5 / PLT < 50×10⁹/L);
- Pregnant or lactating women;
- Patients with BMI < 18.5 kg/m²;
- Patients receiving PICC catheterization via lower extremity veins;
- Patients with known or suspected allergy to components of PICC catheters.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Zeyin Hu, 15899954190, huzy@sysucc.org.cn
About this study
Official title: Effects of Different Tunnel Methods in PICC Catheterization: A Randomized Controlled Trial
This prospective randomized controlled trial compares the effectiveness and safety of one-needle and two-needle tunneling techniques for peripherally inserted central catheter (PICC) placement, aiming to identify the optimal tunneling method to reduce catheter-related complications.
- Conditions
- PICC Line Placement, PICC-associated Thrombosis
- Being tested
- One-needle tunnel technique, two-needle tunnel technique
- Keywords
- tunnel, PICC, complications, thrombosis, infection, bleeding
- Medical subject headings
- Thrombosis, Infections, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-needle tunnel techniqueOther
- Local anesthesia is administered at the puncture site，Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel;
- The guide wire is inserted along the puncture needle;
- skin dilation;
- The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath;
- The catheter tip position is confirmed, and the catheter is secured.
two-needle tunnel techniqueOther
Two-needle tunnel PICC procedure:
- Local anesthesia at puncture and catheter exit sites;
- Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle;
- Skin dilation at both puncture and exit sites;
- 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution;
- Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site;
- Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal;
- Vascular sheath peeled off, catheter adjusted to proper position;
- Catheter tip position confirmed;
- Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.
| Study group | Role | What they receive |
|---|---|---|
| cancer patients who undergo PICC placement using two-needle tunnel technique | Active comparator | Two-needle tunnel PICC procedure:
1. Local anesthesia at puncture and catheter exit sites;
2. Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle;
3. Skin dilation at both puncture and exit sites;
4. 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution;
5. Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site;
6. Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal;
7. Vascular sheath peeled off, catheter adjusted to proper position;
8. Catheter tip position confirmed;
9. Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured. Receives: Other: two-needle tunnel technique |
| cancer patients who undergo PICC placement using one-needle tunnel technique | Experimental | Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation:
1. Local anesthesia is administered at the puncture site，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel;
2. The guide wire is inserted along the puncture needle;
3. skin dilation;
4. The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath;
5. The catheter tip position is confirmed, and the catheter is secured. Receives: Other: One-needle tunnel technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall PICC-related complications after catheter placement
these complications include catheter exit site oozing, contact dermatitis, venous thrombosis, infection, catheter displacement or dislodgement, mechanical phlebitis, catheter occlusion, and catheter fracture or damage.
Measured: 4 weeks after PICC placement
Secondary outcomes (4)
first-puncture success rate of PICC catheterization
Measured: day 1 during PICC catheterization
pain score
Evaluated by Numerical Rating Scale , a self-report tool where individuals rate their pain intensity from 0 (no pain) to 10 (worst possible pain)，with higher scores indicating more severe pain.
Measured: Day 1 during PICC placement
Bleeding during PICC placement
Measured: Day 1 during PICC placement
unplanned catheter removal rate of PICC
Measured: 4 weeks after PICC placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Apr 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PICC Line PlacementStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeyin Hu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594704
- Sponsor's protocol ID
- B2026-068-01
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Tunnel Methods in PICC Catheterization: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07594704
- Acronym / sponsor ID
- B2026-068-01
- Conditions
- PICC Line Placement, PICC-associated Thrombosis
- Keywords
- tunnel, PICC, complications, thrombosis, infection, bleeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 19 May 2026 (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 prospective randomized controlled trial compares the effectiveness and safety of one-needle and two-needle tunneling techniques for peripherally inserted central catheter (PICC) placement, aiming to identify the optimal tunneling method to reduce catheter-related complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cancer patients who undergo PICC placement using two-needle tunnel technique | Active comparator | Other: two-needle tunnel techniqueTwo-needle tunnel PICC procedure: 1. Local anesthesia at puncture and catheter exit sites; 2. Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle; 3. Skin dilation at both puncture and exit sites; 4. 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution; 5. Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site; 6. Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal; 7. Vascular sheath peeled off, catheter adjusted to proper position; 8. Catheter tip position confirmed; 9. Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured. |
| cancer patients who undergo PICC placement using one-needle tunnel technique | Experimental | Other: One-needle tunnel techniqueUltrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation: 1. Local anesthesia is administered at the puncture site，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel; 2. The guide wire is inserted along the puncture needle; 3. skin dilation; 4. The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath; 5. The catheter tip position is confirmed, and the catheter is secured. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged between 18 and 75 years old;
- Educational level of primary school or above, with basic listening, speaking, reading and writing abilities, and capable of completing the questionnaire independently;
- Receiving tunneled PICC catheterization for the first time, with 4Fr single-lumen solo PICC catheter indwelling;
- Able to attend regular PICC maintenance at our hospital as scheduled after catheterization;
- Voluntarily participate in this study and sign the informed consent form for this study as well as the informed consent form for PICC catheterization.
Key exclusion criteria (5 listed)
- Patients with coagulation dysfunction (INR > 1.5 / PLT < 50×10⁹/L);
- Pregnant or lactating women;
- Patients with BMI < 18.5 kg/m²;
- Patients receiving PICC catheterization via lower extremity veins;
- Patients with known or suspected allergy to components of PICC catheters.
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 |
|---|---|---|
| One-needle tunnel technique1. Local anesthesia is administered at the puncture site，Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel; 2. The guide wire is inserted along the puncture needle; 3. skin dilation; 4. The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath; 5. The catheter tip position is confirmed, and the catheter is secured. | Other | cancer patients who undergo PICC placement using one-needle tunnel technique |
| two-needle tunnel techniqueTwo-needle tunnel PICC procedure: 1. Local anesthesia at puncture and catheter exit sites; 2. Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle; 3. Skin dilation at both puncture and exit sites; 4. 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution; 5. Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site; 6. Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal; 7. Vascular sheath peeled off, catheter adjusted to proper position; 8. Catheter tip position confirmed; 9. Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured. | Other | cancer patients who undergo PICC placement using two-needle tunnel technique |
Primary outcome
overall PICC-related complications after catheter placement
Time frame: 4 weeks after PICC placement
these complications include catheter exit site oozing, contact dermatitis, venous thrombosis, infection, catheter displacement or dislodgement, mechanical phlebitis, catheter occlusion, and catheter fracture or damage.
4 secondary outcomes
first-puncture success rate of PICC catheterization
Time frame: day 1 during PICC catheterization
pain score
Time frame: Day 1 during PICC placement
Bleeding during PICC placement
Time frame: Day 1 during PICC placement
unplanned catheter removal rate of PICC
Time frame: 4 weeks after PICC placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for PICC Line Placement
Not yet recruitingObservational study
Image-Guided Central Catheter Insertion With Concurrent Assessment of Vascular Wall Integrity
PICC Line Placement, Vessels; Anomaly
Not yet recruiting
Immersive VR to Reduce Stress, Anxiety, and Pain During PICC/Midline Placement
Vasoconstriction, Biomarkers
Active, not recruitingObservational study
PICC Inserted by a Nurse-led Vascular Access Team in Poland
Vascular Access, PICC Line Placement
Not yet recruitingObservational study
Umbilical Venous Versus Peripherally Inserted Central Catheters in Neonates: A Prospective Cohort Study of Complications, Catheter Survival, and CLABSI"
Peripherally Inserted Central Catheter, Umbilical Venous Catheter
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-needle tunnel technique and two-needle tunnel technique in people with PICC Line Placement and PICC-associated Thrombosis, run by Sun Yat-sen University at 1 site in China.
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 5 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeyin Hu (15899954190, huzy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall PICC-related complications after catheter placement (time frame: 4 weeks after PICC placement). 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 22 May 2026.