Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning

NCT07291869 | Recruiting

• 1 other identifier: 360875
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Rate of catheter malposition

  12-month recruitment window

• Incidence of complications

  Insertion to 48 hours post-procedure

• Inter-operator reliability of IC-ECG and POCUS findings

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

• Proportion of cases which would avoid post-insertion CXR

  12-month recruitment window

• Operator confidence

  Completed within 24 hours of catheter insertion

Study Arms (3)

LEFT internal jugular vein CVC with IC-ECG and thoracic POCUS

ACTIVE COMPARATOR

LEFT internal jugular vein CVC with IC-ECG and thoracic POCUS. Post procedure chest x-ray.

Device: Intracavity ECG; Diagnostic Test: Thoracic point of care ultrasound

RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS

ACTIVE COMPARATOR

RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS. Post procedure chest x-ray.

Device: Intracavity ECG; Diagnostic Test: Thoracic point of care ultrasound

Standard care

NO INTERVENTION

Left or right internal jugular vein CVC. Post procedure CXR.

Interventions

Intracavity ECG DEVICE

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

Also known as: IC-ECG

LEFT internal jugular vein CVC with IC-ECG and thoracic POCUS; RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS

Thoracic point of care ultrasound DIAGNOSTIC_TEST

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

Also known as: POCUS

LEFT internal jugular vein CVC with IC-ECG and thoracic POCUS; RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• York Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, North Yorkshire, YO31 8HE, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 10992821 BACKGROUND

• 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.

  PMID: 33397666 BACKGROUND

Study Officials

• Andrew Chamberlain, MBChB

  York Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Chamberlain, MBChB

CONTACT

+441904 631313; andrew.chamberlain8@nhs.net

Joseph Carter, MBChB

CONTACT

+441904 631313; joseph.carter4@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators analysing post-procedure chest x-rays will be blinded
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, single-centre, open, randomised control study

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 18, 2025
• Study Start: May 15, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

GB (1)