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PICC Line PlacementNCT07888400

IC ECG Combined With Ultrasound Bubble Test for PICC Tip Positioning Among Oncology Adults: A Three Arm Randomized Controlled Trial

A study testing Combined IC-ECG and Ultrasound PICC Tip Location Technique, IC-ECG PICC Tip Location Technique and Ultrasound PICC Tip Location Technique in people with PICC Line Placement and Tip Location, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to learn if using IC-ECG together with ultrasound works better than either method alone to identify the tip position of a PICC in adults with cancer. It will also learn about the safety and efficiency of the combined method. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PICC Line Placement, Tip Location
What is being tested?
Combined IC-ECG and Ultrasound PICC Tip Location Technique, IC-ECG PICC Tip Location Technique and Ultrasound PICC Tip Location Technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
267 participants
Where
1 siteChina
Study dates
16 Jan 2026to 31 Jul 2026
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 who meet the indications for PICC placement and are receiving a PICC catheter via the superior vena cava for the first time;
  • Age greater than 18 years;
  • Patients who are conscious and able to cooperate with the PICC placement procedure and the Valsalva maneuver (holding breath and exhaling forcefully after deep inspiration to increase right atrial pressure);
  • Able to read independently and voluntarily sign the informed consent form.

Who cannot join

  • Patients who are not receiving a PICC catheter for the first time;
  • Patients who are not receiving a PICC catheter for the first time;
  • Patients unable to cooperate with the PICC placement procedure or the Valsalva breathing maneuver;
  • Patients with a history of severe cardiac disease (e.g., heart failure, congenital heart disease, etc.);
  • Patients with anatomical deformities caused by any reason (e.g., kyphosis, morbid obesity, etc.) that make ultrasound diagnosis difficult;
  • Patients with chest trauma (e.g., subcutaneous emphysema, dressings, etc.) that make ultrasound examination difficult to diagnose.Patients unable to cooperate with the PICC placement procedure or the Valsalva breathing maneuver; c. Patients with a history of severe cardiac disease (e.g., heart failure, congenital heart disease, etc.); d. Patients with anatomical deformities caused by any reason (e.g., kyphosis, morbid obesity, etc.) that make ultrasound diagnosis difficult; e. Patients with chest trauma (e.g., subcutaneous emphysema, dressings, etc.) that make ultrasound examination difficult to diagnose.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

The goal of this clinical trial is to learn if using IC-ECG together with ultrasound works better than either method alone to identify the tip position of a PICC in adults with cancer. It will also learn about the safety and efficiency of the combined method.

The main questions it aims to answer are:

Read more

Does the combined method confirm the correct PICC tip position more often than IC-ECG alone or ultrasound alone?

Does the combined method find PICC malposition more accurately?

Does the combined method take less time to complete tip positioning?

What medical problems do participants have during or after the procedure?

Researchers will compare three groups: IC-ECG alone, ultrasound alone, and IC-ECG plus ultrasound. A chest X-ray will be used as the standard check to see if the PICC tip is in the correct place.

Participants will:

Be adults with cancer who need a PICC.

Be assigned by chance to one of the three groups.

Have their PICC placed using the assigned tip-positioning method.

Have a chest X-ray as the usual standard check.

Allow the research team to record the procedure time, success, malposition, and any problems.

Not pay for the IC-ECG or ultrasound tip-positioning tests used in the study. Chest X-ray is part of usual care and will be charged as usual.

This study may help hospitals reduce routine X-ray use after PICC placement, lower radiation exposure, and make PICC placement safer and faster

Being tested
Combined IC-ECG and Ultrasound PICC Tip Location Technique, IC-ECG PICC Tip Location Technique, Ultrasound PICC Tip Location Technique
Keywords
PICC, Tip location, Ultrasound, IC-ECG, Bubble test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined IC-ECG and Ultrasound PICC Tip Location TechniqueProcedure or surgery

    Participants in this arm receive tip location using the combined strategy of IC-ECG and the ultrasound bubble test. Verification is based on both P-wave changes and microbubble observation.

  • IC-ECG PICC Tip Location TechniqueProcedure or surgery

    Participants in this arm receive tip location using only intracavitary electrocardiography (IC-ECG). The tip position is verified in real time by observing the characteristic P-wave changes.

  • Ultrasound PICC Tip Location TechniqueProcedure or surgery

    Participants in this arm receive tip location using only the ultrasound bubble test. The tip position is verified by observing microbubbles in the superior vena cava.

Study groups in NCT07888400
Study groupRoleWhat they receive
IC-ECG PICC Tip Location TechniqueActive comparatorParticipants in this arm receive tip location using only intracavitary electrocardiography (IC-ECG). The tip position is verified in real time by observing the characteristic P-wave changes.
Receives: Procedure: IC-ECG PICC Tip Location Technique
Ultrasound PICC Tip Location TechniqueExperimentalParticipants in this arm receive tip location using only the ultrasound bubble test. The tip position is verified by observing microbubbles in the superior vena cava.
Receives: Procedure: Ultrasound PICC Tip Location Technique
Combined IC-ECG and Ultrasound PICC Tip Location TechniqueExperimentalParticipants in this arm receive tip location using the combined strategy of IC-ECG and the ultrasound bubble test. Verification is based on both P-wave changes and microbubble observation.
Receives: Procedure: Combined IC-ECG and Ultrasound PICC Tip Location Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Optimal PICC tip placement rate

    The proportion of participants whose PICC tip is successfully placed at the optimal position (defined as the lower third of the superior vena cava or the cavoatrial junction), confirmed by chest X-ray (CXR).

    Measured: At the completion of the PICC insertion procedure.

Secondary outcomes (4)
  1. Number of catheter repositioning attempts

    The number of times the catheter was withdrawn and readvanced after malposition (e.g., tip in the internal jugular vein, azygos vein, or right atrium) was confirmed.

    Measured: During the PICC insertion procedure.

  2. Number of localisation procedures

    The number of independent tip-localisation manoeuvres (e.g., IC-ECG recordings or ultrasound scans) performed to confirm the tip position, excluding instances where the catheter was physically repositioned.

    Measured: During the PICC insertion procedure.

  3. Localisation time

    The time from the initiation of tip localisation (i.e., when the catheter reached the estimated insertion length) to the final confirmation of the tip position.

    Measured: During the PICC insertion procedure.

  4. Push-to-bubbles duration

    The duration from the start of agitated saline injection to the visualization of microbubbles in the right atrium, as assessed by transthoracic echocardiography.

    Measured: During the PICC insertion procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start16 Jan 2026
  3. Primary completion31 Jul 2026
  4. Study completion31 Jul 2026

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07888400
Sponsor's protocol ID
B2025 878 01
Status last verified
Oct 2026
First submitted
11 Oct 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vezzani A, Brusasco C, Palermo S, Launo C, Mergoni M, Corradi F. Ultrasound localization of central vein catheter and detection of postprocedural pneumothorax: an alternative to chest radiography. Crit Care Med. 2010 Feb;38(2):533-8. doi: 10.1097/CCM.0b013e3181c0328f.

    PubMed 19829102
  • Pittiruti M, Salerno G, Mancino A, Carlini D, Celentano D, Annetta MG, Conti G. Ultrasound versus intracavitary electrocardiography for intraprocedural tip location during central venous catheterization in infants and children: A prospective clinical study. J Vasc Access. 2024 May;25(3):774-778. doi: 10.1177/11297298221132415. Epub 2022 Oct 20.

    PubMed 36267035
  • Pittiruti M, Pelagatti F, Pinelli F. Intracavitary electrocardiography for tip location during central venous catheterization: A narrative review of 70 years of clinical studies. J Vasc Access. 2021 Sep;22(5):778-785. doi: 10.1177/1129729820929835. Epub 2020 Jun 24.

    PubMed 32578489
  • Yu T, Wu L, Yuan L, Dawson R, Li R, Qiu Z, Wu X, Chen P, Qi J, Yang Y, Feng Y, Xu W, Kong W, Chen Y, Li S, Wu X, Yan T. The diagnostic value of intracavitary electrocardiogram for verifying tip position of peripherally inserted central catheters in cancer patients: A retrospective multicenter study. J Vasc Access. 2019 Nov;20(6):636-645. doi: 10.1177/1129729819838136. Epub 2019 Mar 28.

    PubMed 30919741
  • Liu Z, Zheng X, Zhen Y, Liu X, Lin F, Ye Z, Liu P. Efficacy, Safety, and Cost-Effectiveness of Intracavitary Electrocardiography-Guided Catheter Tip Placement for Totally Implantable Venous Access Port. Ann Vasc Surg. 2022 Jul;83:168-175. doi: 10.1016/j.avsg.2021.11.021. Epub 2021 Dec 20.

    PubMed 34936891
  • Annetta MG, Elli S, Gidaro A, Giustivi D, Iacobone E, Pittiruti M. Ultrasound-based tip navigation and tip location during placement of central venous access devices in adult patients: The ECHOTIP protocol revisited. J Vasc Access. 2026 Mar;27(2):409-415. doi: 10.1177/11297298251347084. Epub 2025 Jun 9.

    PubMed 40491053
  • Goldwasser B, Baia C, Kim M, Taragin BH, Angert RM. Non-central peripherally inserted central catheters in neonatal intensive care: complication rates and longevity of catheters relative to tip position. Pediatr Radiol. 2017 Nov;47(12):1676-1681. doi: 10.1007/s00247-017-3939-1. Epub 2017 Aug 1.

    PubMed 28765996
  • Brescia F, Pittiruti M, Spencer TR, Dawson RB. The SIP protocol update: Eight strategies, incorporating Rapid Peripheral Vein Assessment (RaPeVA), to minimize complications associated with peripherally inserted central catheter insertion. J Vasc Access. 2024 Jan;25(1):5-13. doi: 10.1177/11297298221099838. Epub 2022 May 27.

    PubMed 35633065
  • Meng F, Fan S, Guo L, Jia Z, Chang H, Liu F. Incidence and risk factors of PICC-related thrombosis in breast cancer: a meta-analysis. Jpn J Clin Oncol. 2024 Aug 14;54(8):863-872. doi: 10.1093/jjco/hyae055.

    PubMed 38711392
  • Song L, Li X, Guo Y, Ye M, Ma Y, Guo M, Du N, Li H. Malposition of peripherally inserted central catheter: experience from 3012 cancer patients. Int J Nurs Pract. 2014 Aug;20(4):446-9. doi: 10.1111/ijn.12154. Epub 2013 Aug 30.

    PubMed 25157945
  • Zarkesh MR, Haghjoo M. Neonatal cardiac tamponade, a life-threatening complication secondary to peripherally inserted central catheter: a case report. J Med Case Rep. 2022 Jul 28;16(1):305. doi: 10.1186/s13256-022-03506-4.

    PubMed 35902974
  • Zhu Y, Qin Y, Alvarez JF, Yin W. PICC tip dislodgement causing massive pleural effusion and atelectasis with acute respiratory failure: a case report. BMC Pediatr. 2024 Jul 10;24(1):441. doi: 10.1186/s12887-024-04856-2.

    PubMed 38987700
  • Chen Y, Wang H, Mou Y, Hu S. Tricuspid valve vegetation related to leaflet injury: a unique problem of catheter malposition. Cardiovasc J Afr. 2020 Jul/Aug;31(4):217-220. doi: 10.5830/CVJA-2020-005. Epub 2020 Jun 1.

    PubMed 32490507
  • Nickel B, Gorski L, Kleidon T, Kyes A, DeVries M, Keogh S, Meyer B, Sarver MJ, Crickman R, Ong J, Clare S, Hagle ME. Infusion Therapy Standards of Practice, 9th Edition. J Infus Nurs. 2024 Jan-Feb 01;47(1S Suppl 1):S1-S285. doi: 10.1097/NAN.0000000000000532. No abstract available.

    PubMed 38211609
  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

A study testing Combined IC-ECG and Ultrasound PICC Tip Location Technique, IC-ECG PICC Tip Location Technique and Ultrasound PICC Tip Location Technique in people with PICC Line Placement and Tip Location, 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Oct 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Optimal PICC tip placement rate (time frame: At the completion of the PICC insertion procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07888400, which also lists 15 linked publications.

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 Oct 2026.

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