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Trial registered on ANZCTR
Registration number
ACTRN12626001169336
Ethics application status
Approved
Date submitted
1/09/2026
Date registered
21/09/2026
Date last updated
21/09/2026
Date data sharing statement initially provided
21/09/2026
Type of registration
Retrospectively registered
Titles & IDs
Public title
Using bedside ultrasound to confirm central venous catheter placement in adult intensive care patients
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Scientific title
A randomised controlled trial of point-of-care ultrasound versus standard chest X-ray confirmation of central venous catheter placement in adult intensive care patients: diagnostic accuracy of catheter position confirmation
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Additional trial identifiers [1]
318163
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
ULTRA-CVC (Ultrasound-Led Timely Recognition and Assessment of Central Venous Catheter Placement)
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Related trial records
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Health condition
Health condition(s) studied:
Requirement for central venous catheter insertion in intensive care patients
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Procedural complications of central venous catheter insertion (e.g. pneumothorax, malposition)
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Condition category
Condition code
Anaesthesiology
339562
339562
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0
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Other anaesthesiology
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Public Health
339691
339691
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0
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Health service research
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Cardiovascular
339692
339692
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
Intervention arm: Point-of-care ultrasound (POCUS) plus chest X-ray (CXR).
Following clinically indicated insertion of an internal jugular or subclavian central venous catheter (CVC), bedside POCUS will be performed by an ICU doctor. Ultrasound assessment will include confirmation of the catheter within the cannulated vein, followed by a rapid saline flush through the CVC while imaging the right atrium using a subcostal cardiac ultrasound view. Correct catheter placement will be supported by visualisation of the rapid atrial swirl sign following the saline flush.
If the rapid atrial swirl sign cannot be confidently visualised with a standard saline flush, agitated saline contrast may be used as a secondary confirmation technique.
Bilateral lung ultrasound will also be performed to assess for pneumothorax. A chest X-ray will subsequently be performed in all participants as the current standard method of CVC confirmation. The times of ultrasound and chest X-ray confirmation will be recorded.
Intervention
The bedside POCUS assessment is expected to take approximately 5 minutes, inclusive of vascular confirmation, saline flush/rapid atrial swirl sign assessment, and bilateral lung ultrasound for pneumothorax. The chest X-ray is expected to take approximately 30–45 minutes from request to image availability, in accordance with usual hospital radiology workflow, and will be performed by hospital radiography staff. The POCUS confirmation protocol will be performed once per participant, immediately following clinically indicated CVC insertion; if the catheter is subsequently dislodged or reinserted during the same ICU admission, the protocol may be repeated for the new catheter. Adherence to the POCUS protocol will be monitored via the study data collection form, which records completion of each protocol step, together with proceduralist-reported deviations.
Comparator
The chest X-ray is expected to take approximately 30–45 minutes from request to image availability and will be performed by hospital radiography staff, in accordance with standard hospital practice.
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Intervention code [1]
335225
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Diagnosis / Prognosis
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Description of the comparator or control
Control arm: Standard chest X-ray confirmation.
Following clinically indicated insertion of an internal jugular or subclavian CVC, a chest X-ray will be requested after CVC insertion in accordance with current standard practice. Catheter position and procedure-related complications will be assessed using the chest X-ray, and the time of CVC confirmation using chest X-ray will be recorded. The chest X-ray is expected to take approximately 30–45 minutes from request to image availability and will be performed by hospital radiography staff, in accordance with standard hospital practice.
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Control group
Active
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Outcomes
Primary outcome [1]
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Diagnostic accuracy of point-of-care ultrasound for confirmation of correct central venous catheter placement
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Assessment method [1]
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Point-of-care ultrasound assessment compared with post-insertion chest X-ray as the reference standard. Correct catheter placement on ultrasound will be assessed using the study ultrasound confirmation protocol, including direct vascular visualisation and the rapid atrial swirl sign following a saline flush. Where the rapid atrial swirl sign cannot be confidently visualised, agitated saline contrast may be used as a secondary confirmation technique. Diagnostic agreement between ultrasound and chest X-ray will be assessed. The outcome of this assessment (agreement or discordance between POCUS and chest X-ray findings) will be recorded in the study case report form (REDCap). Underlying ultrasound images and clips are retained on the ultrasound device for verification, and chest X-ray reports are available in the patient's medical record/PACS.
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Timepoint [1]
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Immediately following central venous catheter insertion, with point-of-care ultrasound performed at the bedside and compared with the post-insertion chest X-ray obtained during the same episode of care.
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Secondary outcome [1]
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Time from central venous catheter insertion to confirmation of correct catheter placement
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Assessment method [1]
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Time of central venous catheter insertion and time of confirmation will be recorded prospectively for both point-of-care ultrasound and chest X-ray. Time to confirmation will be calculated separately for each method and compared between study groups. The outcome of this assessment (agreement or discordance between POCUS and chest X-ray findings) will be recorded in the study case report form (REDCap). Underlying ultrasound images and clips are retained on the ultrasound device for verification, and chest X-ray reports are available in the patient's medical record/PACS.
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Timepoint [1]
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From completion of central venous catheter insertion until confirmation by point-of-care ultrasound and chest X-ray during the same episode of care.
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Secondary outcome [2]
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Inter-operator reliability of point-of-care ultrasound assessment for central venous catheter confirmation
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Assessment method [2]
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Agreement between two independent point-of-care ultrasound operators assessing central venous catheter confirmation. Inter-operator agreement will be quantified using Cohen’s kappa for categorical variables or the intraclass correlation coefficient for continuous variables, as appropriate. The outcome of this assessment (agreement or discordance between POCUS and chest X-ray findings) will be recorded in the study case report form (REDCap). Underlying ultrasound images and clips are retained on the ultrasound device for verification, and chest X-ray reports are available in the patient's medical record/PACS.
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Timepoint [2]
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During the point-of-care ultrasound assessment immediately following central venous catheter insertion.
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Secondary outcome [3]
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Diagnostic accuracy of point-of-care ultrasound for detection of post-procedural pneumothorax
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Assessment method [3]
467273
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Bilateral lung ultrasound will be performed following central venous catheter insertion and compared with post-insertion chest X-ray and the reference standard. Agreement and diagnostic accuracy for detection of pneumothorax will be assessed. The outcome of this assessment (agreement or discordance between POCUS and chest X-ray findings) will be recorded in the study case report form (REDCap). Underlying ultrasound images and clips are retained on the ultrasound device for verification, and chest X-ray reports are available in the patient's medical record/PACS.
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Timepoint [3]
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Immediately following central venous catheter insertion during the post-procedural point-of-care ultrasound and chest X-ray assessments.
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Secondary outcome [4]
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Cost of central venous catheter confirmation strategy
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Assessment method [4]
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Direct healthcare resource utilisation associated with point-of-care ultrasound and chest X-ray confirmation will be recorded and compared, including imaging-related resource use and estimated cost per confirmed central venous catheter. The outcome of this assessment (agreement or discordance between POCUS and chest X-ray findings) will be recorded in the study case report form (REDCap). Underlying ultrasound images and clips are retained on the ultrasound device for verification, and chest X-ray reports are available in the patient's medical record/PACS. Costs will be estimated by applying standard hospital costing methodology to the recorded resource use
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Timepoint [4]
467274
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During the index central venous catheter insertion and confirmation episode.
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Secondary outcome [5]
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Time from central venous catheter insertion to first clinical use
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Assessment method [5]
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The time of central venous catheter insertion and the time of first clinical use will be recorded prospectively from study documentation and routine clinical records. Time to first use will be compared between the point-of-care ultrasound confirmation strategy and standard chest X-ray confirmation.
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Timepoint [5]
467276
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From completion of central venous catheter insertion until first clinical use during the same episode of care.
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Secondary outcome [6]
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Adherence to the point-of-care ultrasound central venous catheter confirmation protocol
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Assessment method [6]
467277
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Protocol adherence will be assessed from the study data collection form by recording protocol deviations and whether all required ultrasound confirmation steps were completed. Proceduralists will also provide direct feedback regarding barriers to adoption of the ultrasound confirmation protocol.
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Timepoint [6]
467277
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At completion of the central venous catheter confirmation procedure for each enrolled participant.
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Eligibility
Key inclusion criteria
Adults aged over 18 years admitted to the Intensive Care Unit who require insertion of a central venous catheter in the internal jugular or subclavian vein within the Intensive Care Unit. Eligible catheter types include multilumen central venous catheters and vascular dialysis catheters (VasCath).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
1. Femoral central venous catheter insertion or long-term tunnelled internal jugular/subclavian vascular dialysis catheter.
2. Central venous catheter inserted outside the Intensive Care Unit, including in the Emergency Department or operating theatre.
3. Chest trauma.
4. Known pneumothorax.
5. Current post-cardiothoracic surgery with sternotomy incision.
6. Poor cardiac point-of-care ultrasound windows, including those associated with obesity, anatomical chest deformity or emphysematous lung disease.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed using sequentially numbered, sealed opaque envelopes. Envelopes are opened only after participant eligibility has been confirmed and enrolment has occurred, preventing the treatment allocation from being known in advance.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated blocked randomisation sequence was created using the Sealed Envelope Ltd online blocked randomisation list generator. Participants are allocated in a 1:1 ratio to the ultrasound-led confirmation arm or standard chest X-ray confirmation arm using randomly permuted block sizes of 4 and 6. The randomisation sequence was generated independently of the clinical team.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A total sample size of 132 participants (66 per group) is planned. The original study design specified a target sample size of 80 participants based on 80% statistical power. Prior to review of any unblinded outcome data, the target sample size was revised to increase statistical power and improve the precision of study estimates. A revised a priori two-tailed power calculation using an effect size of d=0.665, alpha=0.05, 95% power and 1:1 allocation indicated a requirement for 120 evaluable participants. The recruitment target was therefore increased to 132 participants (66 per group), allowing approximately 10% attrition due to withdrawals, inadequate imaging and protocol deviations. The decision to increase the sample size was based on methodological considerations and was made independently of interim treatment-effect data.
Diagnostic accuracy of point-of-care ultrasound will be assessed against the formal radiology chest X-ray report as the reference standard. Sensitivity, specificity, overall accuracy, positive and negative likelihood ratios, and agreement will be reported. Paired comparisons will use McNemar's test and paired differences in sensitivity and specificity. Time-to-confirmation outcomes are expected to be right-skewed and will be compared using the Mann-Whitney U test, with the Hodges-Lehmann estimate of the median difference and 95% confidence interval. Inter-operator reliability for ultrasound will be assessed using Cohen's kappa or intraclass correlation coefficient, as appropriate. Other outcomes will be summarised using appropriate descriptive and comparative statistics with measures of variability and 95% confidence intervals.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
4/08/2026
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Date of last participant enrolment
Anticipated
1/01/2028
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Actual
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Date of last data collection
Anticipated
1/01/2028
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Actual
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Sample size
Target
132
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Accrual to date
60
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
30142
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
46536
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
322726
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Hospital
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Name [1]
322726
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Flinders Medical Centre
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Address [1]
322726
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Country [1]
322726
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Australia
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Primary sponsor type
Hospital
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Name
Flinders Medical Centre
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Address
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Country
Australia
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Secondary sponsor category [1]
325820
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None
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Name [1]
325820
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Address [1]
325820
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Country [1]
325820
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
321169
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
321169
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https://www.sahealth.sa.gov.au/wps/wcm/connect/Public+Content/SA+Health+Internet/About+us/Our+Local+Health+Networks/Southern+Adelaide+Local+Health+Network/Research/For+Researchers/Southern+Adelaide+Clinical+Human+Research+Ethics+Committee
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Ethics committee country [1]
321169
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Australia
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Date submitted for ethics approval [1]
321169
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29/09/2025
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Approval date [1]
321169
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15/05/2026
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Ethics approval number [1]
321169
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2025/HRE00384
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Summary
Brief summary
Central venous catheters are commonly inserted in critically ill patients to give medications and other treatments. A chest X-ray is routinely used to confirm that the catheter is correctly positioned and to check for complications, but waiting for an X-ray may delay use of the catheter. This study will investigate whether bedside point-of-care ultrasound can accurately and more rapidly confirm central venous catheter placement in adult intensive care patients compared with standard chest X-ray confirmation. Participants will be randomly allocated to either standard chest X-ray confirmation alone or bedside ultrasound assessment in addition to standard chest X-ray confirmation. The study will assess the accuracy and speed of ultrasound confirmation, its ability to identify complications such as pneumothorax, agreement between ultrasound operators, protocol adherence, and potential effects on healthcare costs and clinical workflow.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Shailesh Bihari
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Address
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Flinders Medical Centre, Intensive Care Unit, Flinders Drive, Bedford Park SA 5042
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Country
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Australia
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Phone
152890
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+61 412112591
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Fax
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Email
152890
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[email protected]
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Contact person for public queries
Name
152891
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Nilesh Anand Devanand
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Address
152891
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Flinders Medical Centre, Intensive Care Unit, Flinders Drive, Bedford Park SA 5042
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Country
152891
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Australia
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Phone
152891
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+61 411531341
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Fax
152891
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Email
152891
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[email protected]
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Contact person for scientific queries
Name
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Nilesh Anand Devanand
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Address
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Flinders Medical Centre, Intensive Care Unit, Flinders Drive, Bedford Park SA 5042
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Country
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Australia
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Phone
152892
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+61 411531341
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Fax
152892
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Email
152892
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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