Examination of The Relationshıp Between Body Mass Index And The Skin-Epidural Space Distance

NCT06316622 | Completed

• 1 other identifier: 2021/08/42
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Anesthesia Awareness

Outcome Measures

Primary Outcomes (1)

• 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.

  six months

Study Arms (1)

volunteer person

EXPERIMENTAL

meausered by ultrasound

Device: ultrasound

Interventions

ultrasound DEVICE

measured by ultrasound

volunteer person

Eligibility Criteria

• Age: 21 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 59 years old.
• ASA I-II classification.
• Body Mass Index (BMI): 18.5-29.9 kg/m2.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (2)

Dokuz Eylul Unicersity

Izmir, Narlidere, 35150, Turkey (Türkiye)

Location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intraoperative Awareness

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Semih Küçükgüçlü, doctor

  Dokuz Eylul University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: relationship between body mass index and the skin epidural space distance
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: relationship between body mass index and the skin epidural space distance

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 18, 2024
• Study Start: March 8, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

TU (2)