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

NCT ID: NCT06316622

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2022-10-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

volunteer person

meausered by ultrasound

Group Type: EXPERIMENTAL

ultrasound

Intervention Type: DEVICE

measured by ultrasound

Interventions

ultrasound

measured by ultrasound

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 59 years old.

2. ASA I-II classification.

3. Body Mass Index (BMI): 18.5-29.9 kg/m2.

Exclusion Criteria

1. Individuals under 18 or over 59 years old.

2. Those with a history of vertebral surgery.

3. Patients diagnosed with spinal deformities (excluding scoliosis ≤10 degrees, kyphosis <30 or >80 degrees).

4. Individuals with rheumatologic diseases affecting skeletal structure such as ankylosing spondylitis, rheumatoid arthritis.

5. Presence of wounds or infections in the lumbar region.

6. Volunteers who underwent epidural or spinal interventions in the lumbar region within the last month.

7. Individuals with bone implants affecting posture, such as hip or knee prostheses.

8. Pregnant women.

9. Individuals with conditions like Cushing's syndrome, hypothyroidism, acromegaly causing lumbar edema.

10. Volunteers using corticosteroids.

11. Obese individuals (BMI: >29.9).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dokuz Eylul University

OTHER

Sponsor Role: lead

Responsible Party

Damla Kaytancı

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semih Küçükgüçlü, doctor

Role: STUDY_CHAIR

Dokuz Eylul University

Locations

Dokuz Eylul Unicersity

Izmir, Narlidere, Turkey (Türkiye)

Dokuz Eylul University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021/08/42

Identifier Type: -

Identifier Source: org_study_id