Plain English Summary
Background and study aims
The intervertebral space (between two adjacent vertebrae in the spine) is estimated before performing spinal and epidural anaesthesia using the palpatory method (using hands). Ultrasound accurately identifies the desired intervertebral spaces, hence avoiding the wrong level of injection and avoiding damage to the spinal cord. The aim of this study is to compare the assessment of intervertebral level by palpation and ultrasound.
Who can participate?
Healthy volunteers aged 18 years and over and anaesthetists with various levels of experience
What does the study involve?
Anaesthetists with various levels of expertise will be asked to palpate the patient's back and to mark the space desired, and the chosen level will be noted. An ultrasound machine will be used by a trained researcher and the correlation between the landmark-estimated space and the ultrasound findings will be noted. Participants’ factors such as age, gender, BMI, and the presence of vertebral malformations (e.g. scoliosis) will be noted.
What are the possible benefits and risks of participating?
Possible benefits include the correct estimation of intervertebral spaces. There are no expected risks.
Where is the study run from?
King Hamad University Hospital (Bahrain)
When is the study starting and how long is it expected to run for?
January 2023 to March 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Surendranath Venkatesan, surendranath.venkatesan@khuh.org.bh
Study website
Contact information
Type
Public, Scientific, Principal Investigator
Contact name
Dr Surendranath Venkatesan
ORCID ID
https://orcid.org/0009-0001-4016-9957
Contact details
Royal Medical Services
Building 2435
Road 2835
Block 228
PO Box 24343
Busaiteen
28
Bahrain
+973 (0)38894263
surendranath.venkatesan@khuh.org.bh
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
A study to evaluate the correlation between anatomical landmark ultrasound imaging estimation of intervertebral level
Acronym
Study hypothesis
Palpation of intervertebral levels may not correctly estimate intervertebral spaces, especially when patients with specific characteristics, such as increased BMI, sclerosed interspinous ligaments and vertebral malformation such as scoliosis, where palpation of the iliac crests and vertebral spinous processes can be difficult. Whereas with ultrasound imaging, the actual intervertebral spaces can be visualized giving a more accurate estimation. Volunteers were recruited to allow anaesthetists to palpate the space manually and it was correlated by ultrasound estimation.
Ethics approval(s)
Approved 28/03/2023, Institutional Review Board - King Hamad University Hospital (Building 2435, Road 2835 Block 228, PO Box 24343, Busaiteen, 228, Bahrain; +973 (0)17444444; khuh@khuh.org.bh), ref: 23-598
Study design
Observational
Primary study design
Observational
Secondary study design
Case series
Study setting(s)
Hospital
Study type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Assessment of intervertebral space
Intervention
Verbal consent will be taken from the volunteer participants. Anaesthetists with various levels of expertise will be asked to palpate the patient's back and to mark the space desired, the chosen level will be noted. An ultrasound machine will be used by a trained researcher and the correlation between the landmark-estimated space and the ultrasound findings will be noted. Participants’ factors such as age, gender, BMI, and the presence of vertebral malformations (e.g. scoliosis) will be noted.
Intervention type
Other
Primary outcome measure
The correlation between anatomical palpation method of intervertebral space estimation and ultrasound estimation. The intervertebral space identified by participants on the two volunteers by the palpatory method was correlated with the ultrasound estimation of the intervertebral space. The difference or agreement between the two different methods was noted. Measured at a single timepoint.
Secondary outcome measures
Measured at a single timepoint:
1. The time taken to estimate by anatomical palpation by participants on volunteers and ultrasound estimation by a trained researcher. A timer was kept as a standard and time from beginning to completion of estimation of the intervertebral space was noted in seconds.
2. The effect of experience on correct estimation, noted from personal interviews with the participants.
Overall study start date
10/01/2023
Overall study end date
31/03/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Willing volunteer
2. Adult volunteer (over 18 years of age)
Participant type(s)
Healthy volunteer
Age group
Adult
Lower age limit
18 Years
Upper age limit
60 Years
Sex
Both
Target number of participants
30
Participant exclusion criteria
1. Age <18 years
2. Pregnant women
3. Back deformities
Recruitment start date
01/04/2023
Recruitment end date
31/03/2024
Locations
Countries of recruitment
Bahrain
Study participating centre
King Hamad University Hospital
Building 2435, Road 2835
Block 228, PO Box 24343
Busaiteen
228
Bahrain
Sponsor information
Organisation
King Hamad University Hospital
Sponsor details
Royal Medical Services
Building 2435
Road 2835
Block 228
PO Box 24343
Busaiteen
228
Bahrain
+973 (0)17444444
khuh@khuh.org.bh
Sponsor type
Hospital/treatment centre
Website
https://www.khuh.org.bh/en/about-khuh
ROR
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
31/12/2024
Individual participant data (IPD) sharing plan
Datasets generated during and/or analysed during the current study will be available upon request from Dr Surendranath Venkatesan (surendranath.venkatesan@khuh.org.bh).
The type of data that will be shared: participants' level of experience, time taken to estimate by palpatory method and ultrasound method and volunteers' age, sex, weight and height will be shared.
Dates of availability: From the last day of completion of study.
Data is anonymised and numbered and the personal identities of both volunteers and participants are concealed.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|