Automated UltraSound Software for Identification of Lumbar Vertebral Levels (AUSSI)

University of British Columbia

Status: Completed

Conditions: Anesthesia

Treatments: Procedure: Automated ultrasound technology identification; Procedure: Manual palpation identification lumbar spine; Procedure: Lumbar level identification gold standard ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT02982317

H16-02858

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: Female

Ages: 19 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

77 participants in 1 patient group

Study group

Description:

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.

Treatment:

Procedure: Manual palpation identification lumbar spine

Procedure: Lumbar level identification gold standard ultrasound

Procedure: Automated ultrasound technology identification