Central Venous CatheterCVC-TIPNCT07291869
Central Venous Catheter Placement With Thoracic Ultrasound and Intracavity ECG Positioning
A study testing Intracavity ECG and Thoracic point of care ultrasound in people with Central Venous Catheter and Point of Care Ultrasound (POCUS), run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheter, Point of Care Ultrasound (POCUS), Intracavitary Electrocardiogram Guiding
- What is being tested?
- Intracavity ECG and Thoracic point of care ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, North Yorkshire, YO31 8HE
Andrew Chamberlain, MBChB, +441904 631313, andrew.chamberlain8@nhs.net
Joseph Carter, MBChB, +441904 631313, joseph.carter4@nhs.net
About this study
Official title: A Randomised Feasibility Study of Real-time Intracavity ECG and Thoracic Ultrasound for Central Venous Catheter Tip Confirmation in Critical Care
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.
Read more
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.
Read the 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.
- Conditions
- Central Venous Catheter, Point of Care Ultrasound (POCUS), Intracavitary Electrocardiogram Guiding, Feasibility Studies
- Being tested
- Intracavity ECG, Thoracic point of care ultrasound
- Keywords
- Intracavity ECG, POCUS, IC-ECG, Thoracic point of care ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracavity ECGDevice
Also called IC-ECG
Vygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning.
Thoracic point of care ultrasoundDiagnostic test
Also called POCUS
Thoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Intracavity ECG; Diagnostic Test: Thoracic point of care ultrasound |
| 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. Receives: Device: Intracavity ECG; Diagnostic Test: Thoracic point of care ultrasound |
| Standard care | No intervention | Left or right internal jugular vein CVC. Post procedure CXR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
How quickly the recruitment target can be achieved within the planned study period
Measured: 12-month recruitment window
Protocol adherence
The number of protocol deviations for all 3 arms
Measured: 12-month recruitment window
Data completeness
The percentage complete data records for each enrolment
Measured: 12-month recruitment window
Training requirements
Feasibility of delivering the required clinician training to ensure safe and consistent implementation of the study protocol
Measured: 12-month recruitment window
Technical success rate
How successful the intervention is when compared to the gold standard chest x-ray
Measured: 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)
Measured: 12-month recruitment window
Secondary outcomes (5)
Rate of catheter malposition
The incidence of central venous catheter malposition on intracavity-ECG and chest x-ray in all treatment arms
Measured: 12-month recruitment window
Incidence of complications
Rate of procedure-related complications occurring during or immediately after insertion.
Measured: 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.
Measured: 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
Measured: 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"
Measured: Completed within 24 hours of catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start15 May 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Venous CatheterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic, single-centre, open, randomised control study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Chamberlain, MBChB, Principal investigator, York Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291869
- Sponsor's protocol ID
- 360875
- Other IDs
- 360875
- Acronym
- CVC-TIP
- Status last verified
- May 2026
- First submitted
- 21 Nov 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 10992821Kang 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.
PubMed 33397666
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Feasibility Study of Real-time Intracavity ECG and Thoracic Ultrasound for Central Venous Catheter Tip Confirmation in Critical Care
- ClinicalTrials.gov ID
- NCT07291869
- Acronym / sponsor ID
- CVC-TIP / 360875
- Conditions
- Central Venous Catheter, Point of Care Ultrasound (POCUS), Intracavitary Electrocardiogram Guiding, Feasibility Studies
- Keywords
- Intracavity ECG, POCUS, IC-ECG, Thoracic point of care ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- York Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Pragmatic, single-centre, open, randomised control study
| Arm | Type | Receives |
|---|---|---|
| LEFT internal jugular vein CVC with IC-ECG and thoracic POCUS | Active comparator | Device: Intracavity ECG, Diagnostic Test: Thoracic point of care ultrasoundLEFT internal jugular vein CVC with IC-ECG and thoracic POCUS. Post procedure chest x-ray. |
| RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS | Active comparator | Device: Intracavity ECG, Diagnostic Test: Thoracic point of care ultrasoundRIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS. Post procedure chest x-ray. |
| Standard care | No intervention | –Left or right internal jugular vein CVC. Post procedure CXR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracavity ECGAlso: IC-ECGVygon PILOT TLS (Tip Location System) used to provide intracavity ECG monitoring for central venous catheter tip positioning. | Device | LEFT internal jugular vein CVC with IC-ECG and thoracic POCUS, RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS |
| Thoracic point of care ultrasoundAlso: POCUSThoracic point of care ultrasound used to scan both lung fields to rule out pneumothorax | Diagnostic test | LEFT internal jugular vein CVC with IC-ECG and thoracic POCUS, RIGHT internal jugular vein CVC with IC-ECG and thoracic POCUS |
Primary outcome
Recruitment Rate
Time frame: 12-month recruitment window
How quickly the recruitment target can be achieved within the planned study period
Protocol adherence
Time frame: 12-month recruitment window
The number of protocol deviations for all 3 arms
Data completeness
Time frame: 12-month recruitment window
The percentage complete data records for each enrolment
Training requirements
Time frame: 12-month recruitment window
Feasibility of delivering the required clinician training to ensure safe and consistent implementation of the study protocol
Technical success rate
Time frame: 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
Time frame: 12-month recruitment window
Time taken from start of procedure to successful confirmation (both using intracavity ECG and chest x-ray)
5 secondary outcomes
Rate of catheter malposition
Time frame: 12-month recruitment window
Incidence of complications
Time frame: Insertion to 48 hours post-procedure
Inter-operator reliability of IC-ECG and POCUS findings
Time frame: Images stored during the procedure and reviewed up to 28 days post-procedure
Proportion of cases which would avoid post-insertion CXR
Time frame: 12-month recruitment window
Operator confidence
Time frame: Completed within 24 hours of catheter insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 10992821Fletcher 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.
- Background: PubMed 33397666Kang 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Chamberlain, MBChB principal investigator
York Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracavity ECG and Thoracic point of care ultrasound in people with Central Venous Catheter and Point of Care Ultrasound (POCUS), run by York Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Chamberlain, MBChB (+441904 631313, andrew.chamberlain8@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 12-month recruitment window). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07291869, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.