Automated UltraSound Software for Identification of Lumbar Vertebral Levels

Study Overview
=================
Brief Summary
-----------------
A novel automated ultrasound software system has been developed which identifies for the practitioner the intervertebral spaces in the lumbar area. This study aims to investigate whether this new technology has a greater accuracy of identifying intervertebral spaces that manual palpation.

Detailed Description
-----------------
The use of ultrasound is one of the most accurate ways to identify the correct vertebral level for needle insertion in spinal/epidural anesthetics, however this is not commonly used. A novel automated ultrasound software system has been developed by the UBC Department of Engineering which identifies for the practitioner the intervertebral spaces in the lumbar area. This study aim to investigate whether this new technology has a greater accuracy of identifying intervertebral spaces that manual palpation.

Official Title
-----------------
Automated UltraSound Software for Identification of Lumbar Vertebral Levels in Obstetric Patients

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Procedure: Manual palpation identification lumbar spine
* Procedure: Automated ultrasound technology identification
* Procedure: Lumbar level identification gold standard ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II ≥ 19 years old Term pregnancy (≥ 37 weeks gestation age) Scheduled for elective Cesarean section Ability to read English in order to understand the consent form Exclusion Criteria: Patient refusal to participate BMI ≥ 40 Scoliosis Previous lower back surgery or known spinal abnormalities Inability to palpate bony landmarks in lumbar region Active labour (cervical dilatation >5cm) Allergy to epidural tape, surgical paper tape, or felt pen

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>All patients recruited will undergo the same protocol. An anesthesiologist will perform manual palpation of the patients lumbar spine and identification of the intervertebral spaces from L1-S1. A member of the UBC Department of Engineering will perform the US scanning and level identification using the novel US technology. In addition, freehand US will be used by two practitioners to determine the participant's lumbar level locations as per gold standard. | Procedure: Manual palpation identification lumbar spine<br> <br> Procedure: Automated ultrasound technology identification<br>* This technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine<br>Procedure: Lumbar level identification gold standard ultrasound<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control) |  | Within 1 hour of recuitment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuraxial anesthesia, Obstetrics, Ultrasound