ClinicalTrials.gg
CompletedNCT07888400Updated Oct 22, 2026

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

An interventional study of Combined IC-ECG and Ultrasound PICC Tip Location Technique and IC-ECG PICC Tip Location Technique in PICC Line Placement and Tip Location, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2026, registered Oct 2026).
Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
267
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

The main questions it aims to answer are:

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

02

Conditions studied

  • PICC Line Placement
  • Tip Location

Keywords

  • PICC
  • Tip location
  • Ultrasound
  • IC-ECG
  • Bubble test
03

In context

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,681 studies on the registry; 610 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
267 participants (actual)

Study arms

  • Active comparator
    IC-ECG PICC Tip Location Technique

    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.

    Procedure: IC-ECG PICC Tip Location Technique

  • Experimental
    Ultrasound PICC Tip Location Technique

    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.

    Procedure: Ultrasound PICC Tip Location Technique

  • Experimental
    Combined IC-ECG and Ultrasound PICC Tip Location Technique

    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.

    Procedure: Combined IC-ECG and Ultrasound PICC Tip Location Technique

Interventions

  • ProcedureCombined IC-ECG and Ultrasound PICC Tip Location Technique

    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.

  • ProcedureIC-ECG PICC Tip Location Technique

    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.

  • ProcedureUltrasound PICC Tip Location Technique

    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.

06

What researchers measure

Primary outcomes

  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).

    Time frame: At the completion of the PICC insertion procedure.

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: During the PICC insertion procedure.

07

Study locations

1 site
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510060, China
08

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 31, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07888400
Responsible party
WU Zhen Ming (Nurse-in-Charge, Sun Yat-sen University) — Principal investigator
First posted
Oct 22, 2026
Start date
Jan 16, 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026
Last update
Oct 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion