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Automated UltraSound Software for Identification of Lumbar Vertebral Levels

NCT ID: NCT02982317

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-05

Study Completion Date

2017-06-15

Brief Summary

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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

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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.

Conditions

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Anesthesia

Keywords

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Neuraxial anesthesia Obstetrics Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

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.

Manual palpation identification lumbar spine

Intervention Type PROCEDURE

Automated ultrasound technology identification

Intervention Type PROCEDURE

This technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine

Lumbar level identification gold standard ultrasound

Intervention Type PROCEDURE

Interventions

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Manual palpation identification lumbar spine

Intervention Type PROCEDURE

Automated ultrasound technology identification

This technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine

Intervention Type PROCEDURE

Lumbar level identification gold standard ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Anton Chau

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anton Chau, MD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of British Columbia

Locations

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BC Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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Hetherington J, Brohan J, Rohling R, Gunka V, Abolmaesumi P, Albert A, Chau A. A novel ultrasound software system for lumbar level identification in obstetric patients. Can J Anaesth. 2022 Oct;69(10):1211-1219. doi: 10.1007/s12630-022-02300-6. Epub 2022 Aug 9.

Reference Type DERIVED
PMID: 35941333 (View on PubMed)

Other Identifiers

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H16-02858

Identifier Type: -

Identifier Source: org_study_id