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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
Scientific title
Validation of Ultrasound Guided Automated Spinal Landmark Identification System (uSINE) in patients with BMI >35
Secondary ID [1] 313284 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstetrics 335618 0
caesarean section 335619 0
pregnancy 335620 0
Condition category
Condition code
Anaesthesiology 332178 332178 0 0
Anaesthetics
Reproductive Health and Childbirth 332179 332179 0 0
Childbirth and postnatal care
Surgery 332252 332252 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 329860 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339767 0
First-attempt success rate of needle insertion for neuraxial anaesthesia for elective Caesarean section
Timepoint [1] 339767 0
At time of procedure only which will be performed at the start of the elective CS
Secondary outcome [1] 441203 0
Number of attempts at needle insertion
Timepoint [1] 441203 0
At time of procedure only which will be performed at the start of the elective CS.
Secondary outcome [2] 441204 0
Time taken for ligamentum flavum to be identified by algorithm
Timepoint [2] 441204 0
At time of procedure only which will be performed at the start of the elective CS
Secondary outcome [3] 441205 0
Depth from skin to ligamentum flavum as detected by the algorithm
Timepoint [3] 441205 0
At time of procedure only which will be performed at the start of the elective CS

Eligibility
Key inclusion criteria
Female patients undergoing elective Caesarean section at Women & Children's Hospital or Lyell McEwin Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317735 0
Commercial sector/Industry
Name [1] 317735 0
Hicura Medical
Country [1] 317735 0
Singapore
Primary sponsor type
Commercial sector/Industry
Name
Hicura Medical
Address
Country
Singapore
Secondary sponsor category [1] 320048 0
None
Name [1] 320048 0
Address [1] 320048 0
Country [1] 320048 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316423 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 316423 0
Ethics committee country [1] 316423 0
Australia
Date submitted for ethics approval [1] 316423 0
11/12/2024
Approval date [1] 316423 0
Ethics approval number [1] 316423 0

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

Contacts
Principal investigator
Name 137842 0
Dr Laura Hewage
Address 137842 0
Women & Children's Hospital, 72 King William Road, Adelaide, SA 5006
Country 137842 0
Australia
Phone 137842 0
+61 432675552
Fax 137842 0
Email 137842 0
laura.hewage@sa.gov.au
Contact person for public queries
Name 137843 0
Laura Hewage
Address 137843 0
Women & Children's Hospital, 72 King William Road, Adelaide, SA 5006
Country 137843 0
Australia
Phone 137843 0
+61 432675552
Fax 137843 0
Email 137843 0
laura.hewage@sa.gov.au
Contact person for scientific queries
Name 137844 0
Van Hoang
Address 137844 0
Lyell McEwin Hospital Campus Haydown Road Elizabeth Vale SA 5112
Country 137844 0
Australia
Phone 137844 0
+61 0881829452
Fax 137844 0
Email 137844 0
van.hoang@sa.gov.au

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


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.