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Trial registered on ANZCTR
Registration number
ACTRN12624001370594p
Ethics application status
Not yet submitted
Date submitted
31/10/2024
Date registered
18/11/2024
Date last updated
18/11/2024
Date data sharing statement initially provided
18/11/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Identifying anatomical landmarks on spinal ultrasound in patients with BMI >35
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Scientific title
Validation of Ultrasound Guided Automated Spinal Landmark Identification System (uSINE) in patients with BMI >35
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Secondary ID [1]
313284
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
obstetrics
335618
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caesarean section
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pregnancy
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Condition category
Condition code
Anaesthesiology
332178
332178
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0
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Anaesthetics
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Reproductive Health and Childbirth
332179
332179
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0
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Childbirth and postnatal care
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Surgery
332252
332252
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Use of an ultrasound algorithm to identify anatomical landmarks when performing neuraxial ultrasound scanning prior to neuraxial anaesthesia for elective Caesarean section.
An ultrasound scan of the lower back will be performed by one of a small group of appropriately trained anaesthetic consultants immediately prior to spinal anaesthesia which will be performed as per standard practice for Caesarean section. The duration of the ultrasound scan will take approximately 15minutes. The ultrasound algorithm will identify the landmarks and these will be used to perform spinal anaesthesia. This is a non-invasive process and not a deviation from standard care.
Adherence and success rate of the procedure (defined as successful needle insertion on 1st attempt) will be recorded contemporaneously.
Training will be provided by Dr Tim Donaldson & Dr Anu Raju who are both investigators on the trial and skilled in neuraxial ultrasound.
The landmarks being identified are:
- depth to ligamentum flavum
- spinous process in the midline
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Intervention code [1]
329860
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Treatment: Devices
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Comparator / control treatment
no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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First-attempt success rate of needle insertion for neuraxial anaesthesia for elective Caesarean section
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Assessment method [1]
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Successful needle insertion as determined by presence of cerebrospinal fluid
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Timepoint [1]
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At time of procedure only which will be performed at the start of the elective CS
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Secondary outcome [1]
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Number of attempts at needle insertion
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Assessment method [1]
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Counting and recording number of needle insertions before successful neuraxial anaesthesia achieved. This will be recorded, along with patient demographic data, on our data collection sheet by the anaesthetist managing the case.
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Timepoint [1]
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At time of procedure only which will be performed at the start of the elective CS.
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Secondary outcome [2]
441204
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Time taken for ligamentum flavum to be identified by algorithm
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Assessment method [2]
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Recording time taken before identification of ligamentum flavum on ultrasound which will be recorded using a timer on the ultrasound machine or if unavailable, the timer on the anaesthetic machine.
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Timepoint [2]
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At time of procedure only which will be performed at the start of the elective CS
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Secondary outcome [3]
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Depth from skin to ligamentum flavum as detected by the algorithm
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Assessment method [3]
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Measurement on ultrasound scanner
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Timepoint [3]
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At time of procedure only which will be performed at the start of the elective CS
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Eligibility
Key inclusion criteria
Female patients undergoing elective Caesarean section at Women & Children's Hospital or Lyell McEwin Hospital
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
i) Patients with an absolute contraindication to neuraxial anaesthesia
ii) If the clinical situation does not permit time for ultrasound scanning due to potential risk to mother and/or foetus
iii) History of scoliosis
iv) History of spinal instrumentation
v) Drug allergy to ultrasound transmission gel
vi) Visible wound or injury in the lumbar spine
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
Single group
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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
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
6/01/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Hicura Medical
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Address [1]
317735
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Country [1]
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Singapore
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Primary sponsor type
Commercial sector/Industry
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Name
Hicura Medical
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Address
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Country
Singapore
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Secondary sponsor category [1]
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None
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Name [1]
320048
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Address [1]
320048
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Country [1]
320048
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Women's and Children's Health Network Human Research Ethics Committee
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Ethics committee address [1]
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https://www.wchn.sa.gov.au/research/human-research
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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11/12/2024
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Approval date [1]
316423
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Ethics approval number [1]
316423
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Summary
Brief summary
The aim of this study is to validate a previously developed machine-learning algorithm for identifying spinal anatomy on ultrasound scanning in patients with BMI >35. We will assess the success-rate of spinal anaesthesia needle insertion using the ultrasound algorithm. Our hypothesis is that the use of ultrasound and the algorithm will improve the first-time success rate of spinal anaesthesia, by making identification of the important landmarks easier for the anaesthetist. This will also reduce complication rates and improve the safety of spinal anaesthesia.
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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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Dr Laura Hewage
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Address
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Women & Children's Hospital, 72 King William Road, Adelaide, SA 5006
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Country
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Australia
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Phone
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+61 432675552
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Fax
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Email
137842
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laura.hewage@sa.gov.au
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Contact person for public queries
Name
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Laura Hewage
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Address
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Women & Children's Hospital, 72 King William Road, Adelaide, SA 5006
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Country
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Australia
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Phone
137843
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+61 432675552
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Fax
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Email
137843
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laura.hewage@sa.gov.au
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Contact person for scientific queries
Name
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Van Hoang
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Address
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Lyell McEwin Hospital Campus Haydown Road Elizabeth Vale SA 5112
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Country
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Australia
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Phone
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+61 0881829452
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Fax
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Email
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van.hoang@sa.gov.au
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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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