Istanbul University - Cerrahpaşa, Cerrahpaşa Faculty of Medicine Hospital
Istanbul, Turkey (Türkiye)
NCT Number: NCT07395115
The prone position in spinal surgery can alter intracranial pressure and optic nerve sheath diameter (ONSD) and potentially lead to visual complications. This prospective observational study aimed to identify factors influencing ultrasonographic ONSD changes and visual acuity in patients undergoing spinal surgery.
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Notify Me18 year and older
All sexes
Observational
Istanbul, Turkey (Türkiye)
During spine surgery, many patients are positioned face-down (prone position) for several hours. This position may influence blood flow to the head and increase pressure around the brain and eyes. One structure that can reflect these pressure changes is the optic nerve sheath, which surrounds the optic nerve at the back of the eye. When the pressure inside the skull rises, the optic nerve sheath may become wider. This change can be measured non-invasively using ultrasound and is referred to as optic nerve sheath diameter (ONSD).
This prospective observational study will evaluate whether ONSD changes occur in adult patients undergoing prone-position spine surgery and whether these changes are related to temporary alterations in vision. Visual acuity will be evaluated using a standard Snellen chart before surgery and on the first postoperative day to detect any change in vision after the procedure.
Ultrasound ONSD measurements will be performed in three stages: before the patient is placed in the prone position, shortly after the prone position is established, and at the end of the surgery while still in the same position. Clinical variables such as blood pressure, carbon dioxide levels, ventilation parameters, anesthesia technique, the use of a pinned head holder, and patient characteristics will also be recorded. By comparing these variables with ONSD and visual outcomes, the study aims to identify whether specific surgical or physiological factors contribute to increased optic nerve sheath width or temporary vision disturbances.
This research does not involve any experimental drug or device. All measurements are part of routine safe monitoring techniques used to assess patients' condition during surgery. The goal of this study is to help better understand factors that may increase the risk of eye-related complications during prone spine surgery and to contribute to safer surgical practices.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline (preoperative, supine), after prone positioning (15 minutes after positioning), and at the end of surgery (intraoperative, before repositioning to supine).
Optic nerve sheath diameter (ONSD) will be measured bilaterally using standardized transorbital ultrasonography with a high-frequency linear probe (6-13 MHz). Measurements will be obtained 3 mm posterior to the globe, in accordance with established sonographic guidelines. For each eye, three measurements will be recorded, and the mean value will be calculated. The average of both eyes will be used for statistical analysis. The primary outcome will be the absolute change in ONSD (ΔONSD, mm) between baseline and intraoperative prone measurements.
Time frame: Baseline (preoperative) and postoperative day 1.
Visual acuity will be initially recorded in decimal format using a standard Snellen chart and subsequently converted to logMAR units for statistical analysis. The outcome will be the absolute change in visual acuity (ΔlogMAR) from baseline to postoperative day 1 (postoperative logMAR minus baseline logMAR).
Time frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and intraoperative end-tidal carbon dioxide levels (EtCO₂, mmHg) recorded simultaneously with ONSD measurements.
Time frame: ntraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
Change in ONSD (mm) will be compared between patients positioned using a pinned head holder and those positioned without pin fixation. The outcome will be the between-group difference in ONSD change (mm).
Time frame: Baseline (preoperative) and postoperative day 1.
The association between postoperative change in visual acuity (ΔlogMAR) and intraoperative change in optic nerve sheath diameter (ΔONSD) will be evaluated using regression analysis. Visual acuity will be recorded in decimal format and converted to logMAR for statistical analysis. ONSD will be measured using standardized transorbital ultrasonography and expressed in millimeters.
Time frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and intraoperative mean arterial pressure (MAP, mmHg) recorded simultaneously with ONSD measurements.
Time frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and arterial partial pressure of carbon dioxide (PaCO₂, mmHg) obtained from arterial blood gas analysis and recorded simultaneously with ONSD measurements.
Time frame: Time Frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and arterial partial pressure of oxygen (PaO₂, mmHg) obtained from arterial blood gas analysis and recorded simultaneously with ONSD measurements.
Time frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and intraoperative positive end-expiratory pressure levels (PEEP, cmH₂O) recorded simultaneously with ONSD measurements.
Istanbul University - Cerrahpasa
Other
Factors Affecting Optic Nerve Sheath Diameter and Visual Acuity Changes in Adult Patients Undergoing Prone Spine Surgery: A Prospective Observational Study
Acronym: PRONE-ONSD
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