A Randomised Feasibility Study of Real-time Intracavity ECG and Thoracic Ultrasound for Central Venous Catheter Tip Confirmation in Critical Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Investigators analysing post-procedure chest x-rays will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Intracavity ECG (Device)
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.
干预措施: Thoracic point of care ultrasound (Diagnostic Test)
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.
干预措施: Intracavity ECG (Device)
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.
干预措施: Thoracic point of care ultrasound (Diagnostic Test)
Standard care
Left or right internal jugular vein CVC. Post procedure CXR.
结局指标
主要结局
Recruitment Rate
时间窗: 12-month recruitment window
How quickly the recruitment target can be achieved within the planned study period
Protocol adherence
时间窗: 12-month recruitment window
The number of protocol deviations for all 3 arms
Data completeness
时间窗: 12-month recruitment window
The percentage complete data records for each enrolment
Training requirements
时间窗: 12-month recruitment window
Feasibility of delivering the required clinician training to ensure safe and consistent implementation of the study protocol
Technical success rate
时间窗: 12-month recruitment window
How successful the intervention is when compared to the gold standard chest x-ray
Time taken for confirmation of central venous catheter tip positioning
时间窗: 12-month recruitment window
Time taken from start of procedure to successful confirmation (both using intracavity ECG and chest x-ray)
次要结局
- Operator confidence(Completed within 24 hours of catheter insertion)
- Rate of catheter malposition(12-month recruitment window)
- Incidence of complications(Insertion to 48 hours post-procedure)
- Inter-operator reliability of IC-ECG and POCUS findings(Images stored during the procedure and reviewed up to 28 days post-procedure)
- Proportion of cases which would avoid post-insertion CXR(12-month recruitment window)