Automated UltraSound Software for Identification of Lumbar Vertebral Levels

Anesthesia Clinical Trial

— AUSSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982317
• Other study ID #: H16-02858
• Status: Completed
• Phase: N/A
• First received: November 15, 2016
• Last updated: November 24, 2017
• Start date: January 5, 2017
• Est. completion date: June 15, 2017

Study information

• Verified date: November 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Manual palpation identification lumbar spine

• 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
• Lumbar level identification gold standard ultrasound

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control)		Within 1 hour of recuitment