Automated UltraSound Software for Identification of Lumbar Vertebral Levels

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Manual palpation identification lumbar spine; Procedure: Automated ultrasound technology identification; Procedure: Lumbar level identification gold standard ultrasound

• Registration Number: NCT02982317
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Study Start: 2017-01-05
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-15
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-24
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Manual palpation identification lumbar spine	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.
Study group	Lumbar level identification gold standard ultrasound	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.
Study group	Automated ultrasound technology identification	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.

Primary Outcome Measures

Name	Time	Method
Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control)	Within 1 hour of recuitment

Trial Locations

Locations (1)

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada