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Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07291869
Acronym
CVC-TIP
Enrollment
75
Registered
2025-12-18
Start date
2026-05-15
Completion date
2027-10-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Catheter, Feasibility Studies, Intracavitary Electrocardiogram Guiding, Point of Care Ultrasound (POCUS)

Keywords

Intracavity ECG, POCUS, IC-ECG, Thoracic point of care ultrasound

Brief summary

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.

Detailed description

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.

Interventions

DEVICEIntracavity ECG

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

DIAGNOSTIC_TESTThoracic point of care ultrasound

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

Sponsors

York Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Masking description

Investigators analysing post-procedure chest x-rays will be blinded

Intervention model description

Pragmatic, single-centre, open, randomised control study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment Rate12-month recruitment windowHow quickly the recruitment target can be achieved within the planned study period
Protocol adherence12-month recruitment windowThe number of protocol deviations for all 3 arms
Data completeness12-month recruitment windowThe percentage complete data records for each enrolment
Training requirements12-month recruitment windowFeasibility of delivering the required clinician training to ensure safe and consistent implementation of the study protocol
Technical success rate12-month recruitment windowHow successful the intervention is when compared to the gold standard chest x-ray
Time taken for confirmation of central venous catheter tip positioning12-month recruitment windowTime taken from start of procedure to successful confirmation (both using intracavity ECG and chest x-ray)

Secondary

MeasureTime frameDescription
Rate of catheter malposition12-month recruitment windowThe incidence of central venous catheter malposition on intracavity-ECG and chest x-ray in all treatment arms
Incidence of complicationsInsertion to 48 hours post-procedureRate of procedure-related complications occurring during or immediately after insertion.
Inter-operator reliability of IC-ECG and POCUS findingsImages stored during the procedure and reviewed up to 28 days post-procedureMeasurement of inter-operator reliability for IC-ECG and POCUS interpretations, using blinded independent review of stored image and waveform data.
Proportion of cases which would avoid post-insertion CXR12-month recruitment windowProportion of catheter insertions where post-procedural a chest x-ray would not be required based on the study criteria
Operator confidenceCompleted within 24 hours of catheter insertionOperator survey for each procedure in the intervention arm, which includes a 5-point Likert confidence scale from "Not Confident" to "Extremely Confident"

Countries

United Kingdom

Contacts

CONTACTAndrew Chamberlain, MBChB
andrew.chamberlain8@nhs.net+441904 631313
CONTACTJoseph Carter, MBChB
joseph.carter4@nhs.net+441904 631313
PRINCIPAL_INVESTIGATORAndrew Chamberlain, MBChB

York Teaching Hospitals NHS Foundation Trust

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026