Anesthesia AwarenessNCT06316622
Examination of The Relationshıp Between Body Mass Index And The Skin-Epidural Space Distance
A study testing ultrasound in people with Anesthesia Awareness, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
Trial summary
Aim: The aim of the study; to investigate whether there is a relationship between body mass index (BMI), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by USG. Read more about this study
- Who is it for?
- Ages 21 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Awareness
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Mar 2021to 1 Oct 2022
- Phase
- Interventional
- 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 21 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 59 years old.
- ASA I-II classification.
- Body Mass Index (BMI): 18.5-29.9 kg/m2.
Who cannot join
- Individuals under 18 or over 59 years old.
- Those with a history of vertebral surgery.
- Patients diagnosed with spinal deformities (excluding scoliosis ≤10 degrees, kyphosis <30 or >80 degrees).
- Individuals with rheumatologic diseases affecting skeletal structure such as ankylosing spondylitis, rheumatoid arthritis.
- Presence of wounds or infections in the lumbar region.
- Volunteers who underwent epidural or spinal interventions in the lumbar region within the last month.
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- Individuals with bone implants affecting posture, such as hip or knee prostheses.
- Pregnant women.
- Individuals with conditions like Cushing's syndrome, hypothyroidism, acromegaly causing lumbar edema.
- Volunteers using corticosteroids.
- Obese individuals (BMI: >29.9).
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Dokuz Eylul Unicersity
Izmir, Narlidere, 35150
Dokuz Eylul University
Izmir
About this study
Official title: Examination of the Relationship Between Body Mass Index and the Skin-epidural Space Distance Measured by Ultrasound in the Lumbar Region
Aim: The aim of the study; to investigate whether there is a relationship between body mass index (BMI), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by USG.
Read the detailed description
The research was carried out in the block room in the preoperating room of Dokuz Eylül University Practice and Research Hospital and with 42 volunteer operating room workers aged between 18-59 years. Height, weight and waist circumference measurements were made with standard measuring instruments, and other measurements were completed by ultrasonography (USG) separately by an anesthesiologist and a radiologist. For ultrasonographic evaluation, left lateral decubitus, right lateral decubitus and in sitting position, skin-dural junction, skin-vertebra corpus, anterior complex distances, upper and lower SIAS levels were examined with convex probe as transverse median. In addition, abdominal subcutaneous fat thickness measurements were made with a linear probe in the supine position. The statistical correlations of all measurements were examined.
- Conditions
- Anesthesia Awareness
- Being tested
- ultrasound
- Medical subject headings
- Intraoperative Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
measured by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| volunteer person | Experimental | meausered by ultrasound Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
We examined the relationships between body mass index calculated by measuring weight and height, subcutaneous fat tissue in the abdominal region and the skin-epidural space distance in the lumbar region; measured by ultrasound.
Unexpectedly low skin-epidural space distances can be seen even in individuals with high weight and fat content.
For the targeted space between above the anterior superior iliac spine (ASIS) (estimated L3-L4) and below the ASIS, each patient was positioned in the left lateral, right lateral and then sitting positions, with a transverse-median approach performed by an anaesthetist followed by a radiologist. Skin-dural composite (SDC), skin-vertebral body and anterior complex (posterior longitudinal ligament) distance measurements were recorded separately. Subcutaneous abdominal fat thickness was measured using a linear probe of an ultrasound device (LOGIQ-E, GE Medical Systems, China) to ensure consistency. Measurements were taken at two points (right lateral, left lateral) 2 cm away from the umbilicus and recorded by averaging. Waist circumference was measured using a standard measuring tape at the navel level in all volunteers.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start8 Mar 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia AwarenessStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- relationship between body mass index and the skin epidural space distance
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Kaytancı, Dokuz Eylul University
- Investigators
- Semih Küçükgüçlü, doctor, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316622
- Sponsor's protocol ID
- 2021/08/42
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Relationship Between Body Mass Index and the Skin-epidural Space Distance Measured by Ultrasound in the Lumbar Region
- ClinicalTrials.gov ID
- NCT06316622
- Acronym / sponsor ID
- 2021/08/42
- Conditions
- Anesthesia Awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 18 Mar 2024 (actual)
- 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.
Aim: The aim of the study; to investigate whether there is a relationship between body mass index (BMI), waist circumference, and abdominal subcutaneous adipose tissue and the skin-epidural space distance measured by USG.
Detailed description
The research was carried out in the block room in the preoperating room of Dokuz Eylül University Practice and Research Hospital and with 42 volunteer operating room workers aged between 18-59 years. Height, weight and waist circumference measurements were made with standard measuring instruments, and other measurements were completed by ultrasonography (USG) separately by an anesthesiologist and a radiologist. For ultrasonographic evaluation, left lateral decubitus, right lateral decubitus and in sitting position, skin-dural junction, skin-vertebra corpus, anterior complex distances, upper and lower SIAS levels were examined with convex probe as transverse median. In addition, abdominal subcutaneous fat thickness measurements were made with a linear probe in the supine position. The statistical correlations of all measurements were examined.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- relationship between body mass index and the skin epidural space distance
| Arm | Type | Receives |
|---|---|---|
| volunteer person | Experimental | Device: ultrasoundmeausered by ultrasound |
Who may qualify
- Ages
- 21 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 59 years old.
- ASA I-II classification.
- Body Mass Index (BMI): 18.5-29.9 kg/m2.
Key exclusion criteria (11 listed)
- Individuals under 18 or over 59 years old.
- Those with a history of vertebral surgery.
- Patients diagnosed with spinal deformities (excluding scoliosis ≤10 degrees, kyphosis <30 or >80 degrees).
- Individuals with rheumatologic diseases affecting skeletal structure such as ankylosing spondylitis, rheumatoid arthritis.
- Presence of wounds or infections in the 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 |
|---|---|---|
| ultrasoundmeasured by ultrasound | Device | volunteer person |
Primary outcome
We examined the relationships between body mass index calculated by measuring weight and height, subcutaneous fat tissue in the abdominal region and the skin-epidural space distance in the lumbar region; measured by ultrasound.
Time frame: six months
Unexpectedly low skin-epidural space distances can be seen even in individuals with high weight and fat content. For the targeted space between above the anterior superior iliac spine (ASIS) (estimated L3-L4) and below the ASIS, each patient was positioned in the left lateral, right lateral and then sitting positions, with a transverse-median approach performed by an anaesthetist followed by a radiologist. Skin-dural composite (SDC), skin-vertebral body and anterior complex (posterior longitudinal ligament) distance measurements were recorded separately. Subcutaneous abdominal fat thickness was measured using a linear probe of an ultrasound device (LOGIQ-E, GE Medical Systems, China) to ensure consistency. Measurements were taken at two points (right lateral, left lateral) 2 cm away from the umbilicus and recorded by averaging. Waist circumference was measured using a standard measuring tape at the navel level in all volunteers.
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 18 Mar 2024.
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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.
Semih Küçükgüçlü, doctor study chair
Dokuz Eylul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Anesthesia Awareness, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
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 3 inclusion and 11 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 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
We examined the relationships between body mass index calculated by measuring weight and height, subcutaneous fat tissue in the abdominal region and the skin-epidural space distance in the lumbar region; measured by ultrasound. (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2024.