Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning (CVC-TIP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Feasibility Studies; Central Venous Catheter; Intracavitary Electrocardiogram Guiding; Point of Care Ultrasound (POCUS)
• Intervention / Treatment: Device: Intracavity ECG; Diagnostic test: Thoracic point of care ultrasound

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Chamberlain, MBChB; Phone Number: +441904 631313; Email: andrew.chamberlain8@nhs.net
• Study Contact Backup: Name: Joseph Carter, MBChB; Phone Number: +441904 631313; Email: joseph.carter4@nhs.net

Study Locations

• United Kingdom
  • North Yorkshire
    • York, North Yorkshire, United Kingdom, YO31 8HE
      • Recruiting
      • York and Scarborough Teaching Hospitals NHS Foundation Trust
      • Contact: Andrew Chamberlain, MBChB; Phone Number: +441904 631313; Email: andrew.chamberlain8@nhs.net
      • Contact: Joseph Carter, MBChB; Phone Number: +441904 631313; Email: joseph.carter4@nhs.net
      • Principal Investigator: Andrew Chamberlain, MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LEFT internal jugular vein CVC with IC-ECG and thoracic POCUS; LEFT internal jugular vein CVC with IC-ECG and thoracic POCUS. Post procedure chest x-ray.	Device: Intracavity ECG; Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.; Other Names: IC-ECG; Diagnostic test: Thoracic point of care ultrasound; Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax; Other Names: POCUS
Active Comparator: RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS; RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS. Post procedure chest x-ray.	Device: Intracavity ECG; Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.; Other Names: IC-ECG; Diagnostic test: Thoracic point of care ultrasound; Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax; Other Names: POCUS
No Intervention: Standard care; Left or right internal jugular vein CVC. Post procedure CXR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	How quickly the recruitment target can be achieved within the planned study period	12-month recruitment window
Protocol adherence	The number of protocol deviations for all 3 arms	12-month recruitment window
Data completeness	The percentage complete data records for each enrolment	12-month recruitment window
Training requirements	Feasibility of delivering the required clinician training to ensure safe and consistent implementation of the study protocol	12-month recruitment window
Technical success rate	How successful the intervention is when compared to the gold standard chest x-ray	12-month recruitment window
Time taken for confirmation of central venous catheter tip positioning	Time taken from start of procedure to successful confirmation (both using intracavity ECG and chest x-ray)	12-month recruitment window

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of catheter malposition	The incidence of central venous catheter malposition on intracavity-ECG and chest x-ray in all treatment arms	12-month recruitment window
Incidence of complications	Rate of procedure-related complications occurring during or immediately after insertion.	Insertion to 48 hours post-procedure
Inter-operator reliability of IC-ECG and POCUS findings	Measurement of inter-operator reliability for IC-ECG and POCUS interpretations, using blinded independent review of stored image and waveform data.	Images stored during the procedure and reviewed up to 28 days post-procedure
Proportion of cases which would avoid post-insertion CXR	Proportion of catheter insertions where post-procedural a chest x-ray would not be required based on the study criteria	12-month recruitment window
Operator confidence	Operator survey for each procedure in the intervention arm, which includes a 5-point Likert confidence scale from "Not Confident" to "Extremely Confident"	Completed within 24 hours of catheter insertion

Collaborators and Investigators

• Sponsor: York Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Andrew Chamberlain, MBChB, York Teaching Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• Fletcher SJ, Bodenham AR. Safe placement of central venous catheters: where should the tip of the catheter lie? Br J Anaesth. 2000 Aug;85(2):188-91. doi: 10.1093/bja/85.2.188. No abstract available.
• Kang M, Bae J, Moon S, Chung TN. Chest radiography for simplified evaluation of central venous catheter tip positioning for safe and accurate haemodynamic monitoring: a retrospective observational study. BMJ Open. 2021 Jan 4;11(1):e041101. doi: 10.1136/bmjopen-2020-041101.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: POCUS; Intracavity ECG; IC-ECG; Thoracic point of care ultrasound
• Other Study ID Numbers: 360875 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymised individual participant data will not be publicly available. Data may be shared on reasonable request with approval from the trial steering committee and subject to a signed data sharing agreement. Shared data will include de-identified procedural and clinical outcome information and may be used for secondary analyses or meta-analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No