Respiratory MechanicsNCT07723690
Ultrasonographic Abdominal Fat Thickness and Driving Pressure During Prone Spinal Surgery
An observational study of Respiratory Mechanics, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Mechanics
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective spinal surgery in the prone position under general anesthesia at a single tertiary care hospital.
Who may be able to join
- 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
Who cannot join
- Emergency surgery Pregnancy Severe restrictive or obstructive pulmonary disease Hemodynamic instability Body mass index <18.5 or ≥40 kg/m² Incomplete study measurements
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Ultrasonographic Abdominal Subcutaneous Fat Thickness and Intraoperative Driving Pressure in Adult Patients Undergoing Elective Prone Spinal Surgery: A Prospective Observational Study
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.
- Conditions
- Respiratory Mechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Driving Pressure
Measured: 10 minutes after prone positioning, before surgical manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MechanicsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yadigar Yılmaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723690
- Sponsor's protocol ID
- SAH-2026-107
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Ultrasonographic Abdominal Subcutaneous Fat Thickness and Intraoperative Driving Pressure in Adult Patients Undergoing Elective Prone Spinal Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07723690
- Acronym / sponsor ID
- SAH-2026-107
- Conditions
- Respiratory Mechanics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 23 Jul 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective spinal surgery in the prone position under general anesthesia at a single tertiary care hospital.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Emergency surgery Pregnancy Severe restrictive or obstructive pulmonary disease Hemodynamic instability Body mass index <18.5 or ≥40 kg/m² Incomplete study measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative Driving Pressure
Time frame: 10 minutes after prone positioning, before surgical manipulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Mechanics, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yadigar YILMAZ (0090 (216) 542 2020, dryadigaryilmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Driving Pressure (time frame: 10 minutes after prone positioning, before surgical manipulation). 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 23 Jul 2026.