Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYork Teaching Hospitals NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intracavity ECG

    Device

    Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.

  • Thoracic point of care ultrasound

    Diagnostic test

    Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: LEFT internal jugular vein CVC with IC-ECG and thoracic POCUSActive comparator 2 interventions
Group B: RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUSActive comparator 2 interventions
Group C: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment Rate

How quickly the recruitment target can be achieved within the planned study period

Time frame
12-month recruitment window
2

Protocol adherence

The number of protocol deviations for all 3 arms

Time frame
12-month recruitment window
3

Data completeness

The percentage complete data records for each enrolment

Time frame
12-month recruitment window
4

Training requirements

Feasibility of delivering the required clinician training to ensure safe and consistent implementation of the study protocol

Time frame
12-month recruitment window

Secondary outcomes

1

Rate of catheter malposition

The incidence of central venous catheter malposition on intracavity-ECG and chest x-ray in all treatment arms

Time frame
12-month recruitment window
2

Incidence of complications

Rate of procedure-related complications occurring during or immediately after insertion.

Time frame
Insertion to 48 hours post-procedure
3

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.

Time frame
Images stored during the procedure and reviewed up to 28 days post-procedure
4

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

Time frame
12-month recruitment window

Other outcomes

Sponsors and contacts

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