Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning

Official title

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

Overview

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

• Device Intracavity ECG
  Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.
• Diagnostic test Thoracic point of care ultrasound
  Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax

Primary outcome measures

• Recruitment Rate [Time frame: 12-month recruitment window]
• Protocol adherence [Time frame: 12-month recruitment window]
• Data completeness [Time frame: 12-month recruitment window]
• Training requirements [Time frame: 12-month recruitment window]
• Technical success rate [Time frame: 12-month recruitment window]
• Time taken for confirmation of central venous catheter tip positioning [Time frame: 12-month recruitment window]

Secondary outcome measures (5)

• Rate of catheter malposition [Time frame: 12-month recruitment window]
• Incidence of complications [Time frame: Insertion to 48 hours post-procedure]
• Inter-operator reliability of IC-ECG and POCUS findings [Time frame: Images stored during the procedure and reviewed up to 28 days post-procedure]
• Proportion of cases which would avoid post-insertion CXR [Time frame: 12-month recruitment window]
• Operator confidence [Time frame: Completed within 24 hours of catheter insertion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Basic science

Study locations

United Kingdom · 1 center

• York and Scarborough Teaching Hospitals NHS Foundation Trust — York

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. PMID 10992821
• 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

Identifiers

NCT: NCT07291869 · 360875 · 360875

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗