None listed
Conditions
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.
Interventions
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 a
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
Sponsors
Hicura Medical
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Female patients undergoing elective Caesarean section at Women & Children's Hospital or Lyell McEwin Hospital
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
Outcome results
None listed