NCT07723690

Brief Summary

This prospective observational study aims to evaluate the association between preoperative abdominal subcutaneous fat thickness measured by ultrasonography and intraoperative driving pressure in adult patients undergoing elective spinal surgery in the prone position under general anesthesia. Anthropometric measurements including body mass index, waist circumference, waist-to-height ratio, and neck circumference will also be evaluated for their association with respiratory mechanics. No additional intervention beyond routine clinical care will be performed.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Jul 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Nov 2026

First Submitted

Initial submission to the registry

July 19, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

July 30, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 19, 2026

Last Update Submit

July 19, 2026

Conditions

Respiratory Mechanics

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Driving Pressure

    10 minutes after prone positioning, before surgical manipulation

Study Arms (1)

Adult patients undergoing elective prone spinal surgery

Adult patients undergoing elective spinal surgery in the prone position under general anesthesia. Preoperative ultrasonographic abdominal subcutaneous fat thickness and intraoperative respiratory mechanics will be evaluated.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective spinal surgery in the prone position under general anesthesia at a single tertiary care hospital.

You may qualify if:

  • Adults aged 18 years or older Elective spinal surgery General anesthesia Prone position ASA physical status I-III Body mass index 18.5-39.9 kg/m²

You may not qualify if:

  • Emergency surgery Pregnancy Severe restrictive or obstructive pulmonary disease Hemodynamic instability Body mass index \<18.5 or ≥40 kg/m² Incomplete study measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

yadigar YILMAZ

CONTACT

0090 (216) 542 2020dryadigaryilmaz@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 19, 2026

First Posted

July 23, 2026

Study Start

July 30, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07