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NCT Number: NCT07291869

Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning

The goal of this interventional study is to assess the feasibility of two bedside techniques for confirming central venous catheter (CVC) placement and detecting complications:

* Intracavity ECG monitoring to confirm internal jugular vein CVC tip position. * Thoracic point-of-care ultrasound (POCUS) to rule out pneumothorax following CVC insertion.

Participants who require an internal jugular CVC as part of their routine care and meet all inclusion and no exclusion criteria will be randomised to receive either:

* Standard care, or * The intervention, consisting of intracavity ECG guidance and thoracic POCUS. The CVC will be inserted either on the left or right side of the neck.

All participants will undergo a post-procedure chest X-ray regardless of study arm, to allow comparison of the intervention methods with standard care.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, North Yorkshire, YO31 8HE, United Kingdom

Location status: Recruiting

Location contact

Andrew Chamberlain, MBChB

CONTACT

[email protected]

+441904 631313

Andrew Chamberlain, MBChB

PRINCIPAL_INVESTIGATOR

Joseph Carter, MBChB

CONTACT

[email protected]

+441904 631313

About this study

Central venous catheters (CVCs) are commonly inserted in critically ill patients to enable the administration of medications, fluids, and monitoring. Following insertion, it is standard practice to perform a chest X-ray (CXR) to confirm correct catheter tip position and exclude complications such as pneumothorax. However, reliance on post-procedure radiography can delay verification of line position, increase patient radiation exposure, and contribute to workflow inefficiency.

Alternative bedside techniques have been proposed to improve the speed and safety of CVC verification. Intracavity electrocardiography (IC-ECG) uses the patient's cardiac electrical activity to confirm the catheter tip's location in real time. When the catheter tip approaches the cavoatrial junction, a characteristic increase in P-wave amplitude is observed, allowing for accurate placement without the need for immediate imaging. Thoracic point-of-care ultrasound (POCUS) has been shown to be an effective method for detecting pneumothorax following CVC insertion.

This single-centre, prospective, randomised feasibility study will evaluate the combined use of intracavity ECG for tip confirmation and thoracic POCUS for pneumothorax exclusion in patients requiring internal jugular CVC insertion. Eligible participants will be randomised to receive either:

  • Standard care (ultrasound-guided insertion with post-procedure CXR), or
  • The intervention, consisting of ultrasound-guided insertion supplemented with intracavity ECG confirmation and thoracic POCUS assessment, followed by a post-procedure CXR for comparison.

The primary objective is to determine the feasibility of implementing these combined techniques within a critical care environment, including assessment of recruitment, protocol adherence, and completeness of data acquisition. Secondary outcomes include the accuracy of IC-ECG and POCUS compared to CXR for tip position and pneumothorax detection, and the time required to confirm line placement.

The findings will inform the design of a future multi-centre study to assess diagnostic accuracy, cost-effectiveness, and potential to replace routine post-procedure chest X-ray in appropriate clinical settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (aged ≥ 18 years)
  • Admitted, or planned for admission, to critical care
  • Requiring central venous catheter insertion as a part of their usual care
  • Suitable for both right or left internal jugular vein insertion

Exclusion criteria

  • Previously randomised into CVC-TIP
  • Atrial fibrillation on 12-lead ECG
  • Cardiovascular instability, defined as
  • Noradrenaline dose > 0.5mcg/kg/min
  • Rapidly escalating doses of vasopressors / inotropes
  • Difficulty in obtaining thoracic ultrasound images due to either
  • Weight > 120kg
  • Existing pneumothorax (either side)
  • Subcutaneous emphysema
  • Wounds / dressing over anterior chest wall
  • Existing pacemaker
  • Non-English speaking participants
  • Death perceived as imminent
  • Any other reason as determined by treating clinician

Treatment and study plan

Intracavity ECG

Device

Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.

Other names: IC-ECG

Thoracic point of care ultrasound

Diagnostic Test

Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax

Other names: POCUS

Primary outcomes

  1. Recruitment Rate

    Time frame: 12-month recruitment window

    How quickly the recruitment target can be achieved within the planned study period

  2. Protocol adherence

    Time frame: 12-month recruitment window

    The number of protocol deviations for all 3 arms

  3. Data completeness

    Time frame: 12-month recruitment window

    The percentage complete data records for each enrolment

  4. Training requirements

    Time frame: 12-month recruitment window

    Feasibility of delivering the required clinician training to ensure safe and consistent implementation of the study protocol

  5. Technical success rate

    Time frame: 12-month recruitment window

    How successful the intervention is when compared to the gold standard chest x-ray

  6. Time taken for confirmation of central venous catheter tip positioning

    Time frame: 12-month recruitment window

    Time taken from start of procedure to successful confirmation (both using intracavity ECG and chest x-ray)

Secondary outcomes

  1. Rate of catheter malposition

    Time frame: 12-month recruitment window

    The incidence of central venous catheter malposition on intracavity-ECG and chest x-ray in all treatment arms

  2. Incidence of complications

    Time frame: Insertion to 48 hours post-procedure

    Rate of procedure-related complications occurring during or immediately after insertion.

  3. Inter-operator reliability of IC-ECG and POCUS findings

    Time frame: Images stored during the procedure and reviewed up to 28 days post-procedure

    Measurement of inter-operator reliability for IC-ECG and POCUS interpretations, using blinded independent review of stored image and waveform data.

  4. Proportion of cases which would avoid post-insertion CXR

    Time frame: 12-month recruitment window

    Proportion of catheter insertions where post-procedural a chest x-ray would not be required based on the study criteria

  5. Operator confidence

    Time frame: Completed within 24 hours of catheter insertion

    Operator survey for each procedure in the intervention arm, which includes a 5-point Likert confidence scale from "Not Confident" to "Extremely Confident"

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew Chamberlain, MBChB

CONTACT

[email protected]

+441904 631313

Joseph Carter, MBChB

CONTACT

[email protected]

+441904 631313

Sponsors and collaborators

Lead sponsor

York Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

A Randomised Feasibility Study of Real-time Intracavity ECG and Thoracic Ultrasound for Central Venous Catheter Tip Confirmation in Critical Care

Acronym: CVC-TIP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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