AnesthesiaAUSSINCT02982317
Automated UltraSound Software for Identification of Lumbar Vertebral Levels
An observational study of Anesthesia, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Manual palpation identification lumbar spine, Automated ultrasound technology identification and Lumbar level identification gold standard ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jan 2017to 15 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Parturients scheduled for an elective Cesarean section at BC Women's Hospital
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Manual palpation identification lumbar spine, Automated ultrasound technology identification, Lumbar level identification gold standard ultrasound
- Keywords
- Neuraxial anesthesia, Obstetrics, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual palpation identification lumbar spineProcedure or surgery
Automated ultrasound technology identificationProcedure or surgery
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 ultrasoundProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Manual palpation identification lumbar spine; Procedure: Automated ultrasound technology identification; Procedure: Lumbar level identification gold standard ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control)
Measured: Within 1 hour of recuitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start5 Jan 2017
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anton Chau, University of British Columbia
- Investigators
- Anton Chau, MD, Principal investigator, Univeristy of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982317
- Sponsor's protocol ID
- H16-02858
- Acronym
- AUSSI
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2016
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35941333
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated UltraSound Software for Identification of Lumbar Vertebral Levels in Obstetric Patients
- ClinicalTrials.gov ID
- NCT02982317
- Acronym / sponsor ID
- AUSSI / H16-02858
- Conditions
- Anesthesia
- Keywords
- Neuraxial anesthesia, Obstetrics, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Manual palpation identification lumbar spine, Procedure: Automated ultrasound technology identification, Procedure: Lumbar level identification gold standard ultrasoundAll 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. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Parturients scheduled for an elective Cesarean section at BC Women's Hospital
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Patient refusal to participate
- BMI ≥ 40
- Scoliosis
- Previous lower back surgery or known spinal abnormalities
- Inability to palpate bony landmarks in lumbar region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual palpation identification lumbar spine | Procedure or surgery | Study group |
| Automated ultrasound technology identificationThis technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine | Procedure or surgery | Study group |
| Lumbar level identification gold standard ultrasound | Procedure or surgery | Study group |
Primary outcome
Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control)
Time frame: Within 1 hour of recuitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Derived from this study: PubMed 35941333Hetherington 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anton Chau, MD principal investigator
Univeristy of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control) (time frame: Within 1 hour of recuitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.