Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT07291869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning
Sponsor:
York Teaching Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
A Randomised Feasibility Study of Real-time Intracavity ECG and Thoracic Ultrasound for Central Venous Catheter Tip Confirmation in Critical Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVC-TIP
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.
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 360875 | OTHER | IRAS | View |