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Trial registered on ANZCTR


Registration number
ACTRN12624001187538p
Ethics application status
Submitted, not yet approved
Date submitted
17/10/2023
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of a miniature transoesophageal echocardiography (TOE) device to assess shock in trauma patients requiring rescuscitation
Scientific title
Transoesophageal echocardiography (TOE) in the early assessment of shocked trauma: A pilot study of a novel disposable miniaturised TOE device in the first hour of resuscitation.
Secondary ID [1] 310329 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shock 331056 0
Condition category
Condition code
Emergency medicine 327848 327848 0 0
Resuscitation
Cardiovascular 331491 331491 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ClariTEE® Hemydynamic Ultrasound probe is a transoesophageal echocardiography (TOE) device. The TOE device is a miniature ultrasound camera on the end of a thin, flexible tube. It is inserted via the mouth and positioned in oesophagus behind the heart from where high definition close up ultrasound images of the heart can be obtained. The TOE is similar in size to routinely used nasogastric tubes. This device is expected to be inserted once within 60min of presentation to ED and will remain in position for up to 20 minutes to allow adequate visualisation of the heart. The TOE will be used to assess shock in patients with major trauma who require resuscitation. It will only be used by doctors in the emergency department who have been trained in how to properly use it. The findings recorded by the clinician will be checked against the CT scan and / or operative findings to assess accuracy and sensitivity of this investigation.
Intervention code [1] 326728 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335691 0
This is a feasibility study, assessing the clinicians ability to assess shock using the device. The primary outcome is the collapsibility index of the superior vena cava (two measurements of the maximum and minimum width of the SVC) as a validated marker of hypovolaemia. This will be reported as the proportion of patients where clinicians are able to achieve views of the heart sufficient to calculate this index within 10 minutes of insertion of the probe.
Timepoint [1] 335691 0
After completing the examination the clinician will report their findings into an App based survey. The primary timepoints will be whether the clinician could obtain the necessary views of the heart within 10 minutes of insertion. This data entry will be completed as soon after the procedure as patient stability allows (likely within 60 minutes).
Secondary outcome [1] 427916 0
The first secondary outcome include questions on ease of image acquisition / capture using a visual analogue scale as well as free text entry on the logistics of using the device within the resuscitation setting.
Timepoint [1] 427916 0
This data will be captured by an App. This App / audit tool will be created to capture the primary and secondary endpoints and will be entered by the clinician as soon after the procedure as patient stability allows (likely within 60 minutes)
Secondary outcome [2] 439969 0
Another secondary outcome will be a composite outcome: 'additional shock pathologies'. This will be an assessment of whether the device allowed identification of any other pathologies which could have caused / exacerbated the shock state. This will include a checkbox list of pathologies that were able to be identified during the examination, i.e. other cause of shock including cardiac tamponade, pulmonary embolism and haemothorax.
Timepoint [2] 439969 0
This data will be captured by an App. This App / audit tool will be created to capture the primary and secondary endpoints and will be entered by the clinician as soon after the procedure as patient stability allows (likely within 60 minutes)

Eligibility
Key inclusion criteria
Intubated major trauma patients presenting during the study period
Age 18 years and over
Presenting directly from scene of injury
Meeting ‘shocked trauma’ callout criteria:
- Systolic blood pressure (SBP) less than 90mmHg at any time
- Shock index > 1 (Heart Rate/SBP)
- Prehospital blood transfusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not requiring intubation either prehospital or within 1 hour of arrival to the ED
- Deceased on arrival
- An Advanced Care Directive that precludes resuscitation

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will aim to recruit 10 participants. Data will be collected from two sources for this study – data collected at the time of the procedure entered by the proceduralist into an online survey form, and data from subjects’ electronical medical records (EMR). Normal or near-normal distributed data will be summarized using mean (standard deviation) while skewed and ordinal data will be summarized using medians (inter-quartile range). Statistical significance will be assessed by Student’s t-test (for difference between means), Wilcoxon Rank Sum test (for difference between medians) and the Chi-squared test (for difference between proportions) or Fisher’s Exact test (for difference between proportions when value in a cell is <5). A p-value of <0.05 will be defined to be statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25492 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 41060 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 314534 0
Other
Name [1] 314534 0
National Trauma Research Institute
Country [1] 314534 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Christopher Groombridge
Address
Level 4, 89 Commercial Rd, Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 316712 0
None
Name [1] 316712 0
Address [1] 316712 0
Country [1] 316712 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313576 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 313576 0
Ethics committee country [1] 313576 0
Australia
Date submitted for ethics approval [1] 313576 0
06/09/2023
Approval date [1] 313576 0
Ethics approval number [1] 313576 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128610 0
A/Prof Christopher Groombridge
Address 128610 0
The National Trauma Research Institute, Level 4, 89 Commercial Rd Melbourne, Victoria 3004
Country 128610 0
Australia
Phone 128610 0
+61 0390768805
Fax 128610 0
Email 128610 0
c.groombridge@alfred.org.au
Contact person for public queries
Name 128611 0
Christopher Groombridge
Address 128611 0
The National Trauma Research Institute, Level 4, 89 Commercial Rd Melbourne, Victoria 3004
Country 128611 0
Australia
Phone 128611 0
+61 0390768805
Fax 128611 0
Email 128611 0
c.groombridge@alfred.org.au
Contact person for scientific queries
Name 128612 0
Christopher Groombridge
Address 128612 0
The National Trauma Research Institute, Level 4, 89 Commercial Rd Melbourne, Victoria 3004
Country 128612 0
Australia
Phone 128612 0
+61 0390768805
Fax 128612 0
Email 128612 0
c.groombridge@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect participant privacy


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.