About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previously randomised into CVC-TIP
Atrial fibrillation on 12-lead ECG
Cardiovascular instability, defined as
Noradrenaline dose > 0.5mcg/kg/min
Trial design
Parallel
Treatments tested in this trial
Intracavity ECG
DeviceVygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.
Thoracic point of care ultrasound
Diagnostic testThoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax
Treatment groups
Trial outcomes
Primary outcomes
Recruitment Rate
How quickly the recruitment target can be achieved within the planned study period
Protocol adherence
The number of protocol deviations for all 3 arms
Data completeness
The percentage complete data records for each enrolment
Training requirements
Feasibility of delivering the required clinician training to ensure safe and consistent implementation of the study protocol
Secondary outcomes
Rate of catheter malposition
The incidence of central venous catheter malposition on intracavity-ECG and chest x-ray in all treatment arms
Incidence of complications
Rate of procedure-related complications occurring during or immediately after insertion.
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.
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
Sponsors and contacts
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