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| ID | Type | Description | Link |
|---|---|---|---|
| 360875 | Other Identifier | IRAS |
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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:
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:
All participants will undergo a post-procedure chest X-ray regardless of study arm, to allow comparison of the intervention methods with standard care.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Standard care | No Intervention | Left or right internal jugular vein CVC. Post procedure CXR. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracavity ECG | Device | Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Chamberlain, MBChB | Contact | +441904 631313 | andrew.chamberlain8@nhs.net | |
| Joseph Carter, MBChB | Contact | +441904 631313 | joseph.carter4@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Chamberlain, MBChB | York Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| York and Scarborough Teaching Hospitals NHS Foundation Trust | Recruiting | York | North Yorkshire | YO31 8HE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10992821 | Background | 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. | |
| 33397666 | 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. |
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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.
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Pragmatic, single-centre, open, randomised control study
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Investigators analysing post-procedure chest x-rays will be blinded
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| Thoracic point of care ultrasound | Diagnostic Test | Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax |
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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 |