Automated UltraSound Software for Identification of Lumbar Vertebral Levels (AUSSI)
November 24, 2017 updated by: Anton Chau, University of British Columbia
Automated UltraSound Software for Identification of Lumbar Vertebral Levels in Obstetric Patients
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
77
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6H3N1
- BC Women's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Parturients scheduled for an elective Cesarean section at BC Women's Hospital
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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This technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control)
Time Frame: Within 1 hour of recuitment
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Within 1 hour of recuitment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anton Chau, MD, Univeristy of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2017
Primary Completion (Actual)
June 15, 2017
Study Completion (Actual)
June 15, 2017
Study Registration Dates
First Submitted
November 15, 2016
First Submitted That Met QC Criteria
November 30, 2016
First Posted (Estimate)
December 5, 2016
Study Record Updates
Last Update Posted (Actual)
November 28, 2017
Last Update Submitted That Met QC Criteria
November 24, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H16-02858
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.