Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning
NCT ID: NCT07291869
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
75 participants
INTERVENTIONAL
2026-01-31
2027-01-31
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
Intracavity ECG
Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.
Thoracic point of care ultrasound
Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax
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.
Intracavity ECG
Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.
Thoracic point of care ultrasound
Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax
Standard care
Left or right internal jugular vein CVC. Post procedure CXR.
No interventions assigned to this group
Interventions
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Intracavity ECG
Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.
Thoracic point of care ultrasound
Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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York Teaching Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Andrew Chamberlain, MBChB
Role: PRINCIPAL_INVESTIGATOR
York Teaching Hospitals NHS Foundation Trust
Locations
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York and Scarborough Teaching Hospitals NHS Foundation Trust
York, North Yorkshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Andrew Chamberlain, MBChB
Role: primary
Joseph Carter, MBChB
Role: backup
References
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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.
Other Identifiers
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360875
Identifier Type: -
Identifier Source: org_study_id
360875
Identifier Type: OTHER
Identifier Source: secondary_id