Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07291869

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

Led by York Teaching Hospitals NHS Foundation Trust · Updated on 2026-06-02

75

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the feasibility of two bedside methods to confirm the placement of central venous catheters (CVCs) and detect complications in critically ill patients. It compares intracavity electrocardiography (IC-ECG), which monitors heart electrical activity to guide catheter tip position, and thoracic point-of-care ultrasound (POCUS), which checks for pneumothorax after CVC insertion. The study is a single-center, prospective, randomized feasibility trial to improve speed and safety in CVC verification compared to standard chest X-ray. Participants needing an internal jugular vein CVC will be randomly assigned to one of three groups: CVC insertion on the left side with IC-ECG and thoracic POCUS, CVC insertion on the right side with these techniques, or standard care involving ultrasound-guided insertion with post-procedure chest X-ray only. All participants will receive a chest X-ray after the procedure to compare the new methods with standard care. Throughout the 12-month recruitment period, researchers will measure recruitment rates, protocol adherence, data completeness, technical success, and time taken to confirm catheter tip position. They will also monitor complications up to 48 hours after insertion, review ultrasound and ECG images for consistency, assess operator confidence, and evaluate how often chest X-rays might be avoided. The study will help design larger future trials to assess accuracy and cost-effectiveness of these techniques in critical care.

CONDITIONS

Brief Title

Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (aged 65 18 years)
  • Admitted, or planned for admission, to critical care
  • Requiring central venous catheter insertion as a part of usual care
  • Suitable for insertion in either right or left internal jugular vein
Not Eligible

You will not qualify if you...

  • Previously randomised into this study
  • Atrial fibrillation on 12-lead ECG
  • Cardiovascular instability, including noradrenaline dose above 0.5 mcg/kg/min or rapidly increasing vasopressor doses
  • Difficulty obtaining thoracic ultrasound images due to weight over 120kg, existing pneumothorax, subcutaneous emphysema, or chest wall wounds/dressings
  • Existing pacemaker
  • Non-English speaking
  • Imminent death perceived
  • Any other reason judged by treating clinician to exclude participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Central Venous Catheter Placement

Duration - Procedure day

Participants undergo insertion of a central venous catheter (CVC) in either the left or right internal jugular vein, guided by ultrasound. Depending on randomization, catheter tip confirmation is performed using intracavity ECG and thoracic point-of-care ultrasound to assess catheter position and exclude pneumothorax.

1 procedure visit (in-person)

Post-procedure Chest X-ray and Monitoring

Duration - Up to 48 hours post-procedure

After catheter placement, participants receive a chest X-ray to confirm catheter tip position and check for complications. Participants are monitored for complications for up to 48 hours post-procedure.

Approximately 1 to 2 visits within 48 hours

Follow-up Image Review and Assessment

Duration - Up to 28 days post-procedure

Images obtained during the procedure are reviewed up to 28 days post-procedure to assess inter-operator reliability of intracavity ECG and thoracic ultrasound findings.

No direct participant visits; assessments conducted through image review

Trial Site Locations

Total: 1 location

1

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, North Yorkshire, United Kingdom, YO31 8HE

Actively Recruiting

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Research Team

A

Andrew Chamberlain, MBChB

J

Joseph Carter, MBChB

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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Published Research Related To This Trial

Chest radiography for simplified evaluation of central venous catheter tip positioning for safe and accurate haemodynamic monitoring: a retrospective observational study.

Minwoo Kang, Jinkun Bae, Sujin Moon...

https://pubmed.ncbi.nlm.nih.gov/33397666