Lumbar Disc HerniationNCT07862257
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
An observational study of Lumbar Disc Herniation and Respiratory Mechanics, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the relationship between changes in respiratory mechanics and cerebral oxygenation in adult patients undergoing elective lumbar disc surgery in the prone position under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Disc Herniation, Respiratory Mechanics, Cerebral Oxygenation
- What is being tested?
- Prone Positioning
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2026to 30 Jan 2027
- Phase
- Observational
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18-75 years undergoing elective lumbar disc herniation surgery in the prone position under general anesthesia at Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital.
Who may be able to join
- Age 18-75 years
- Written informed consent
- Scheduled for elective lumbar disc herniation surgery
- ASA physical status I-III
- Volume-controlled ventilation
Who cannot join
- History of increased intracranial pressure
- Conditions preventing placement of cerebral NIRS probes
- Development of severe intraoperative complications
- Significant hemodynamic instability
- Known cerebrovascular disease or severe carotid artery disease
- Hemoglobin <10 g/dL or anticipated major bleeding
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- Severe heart failure (EF <40%)
- Advanced COPD or restrictive lung disease
- Orthopedic or neurological conditions preventing tolerance of the prone position
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
Istanbul, Istanbul, 34000
Birhan Karaca, MD, +90 216 606 33 00, birhan.karaca93@hotmail.com
About this study
Official title: Evaluation of the Relationship Between Changes in Pulmonary Mechanics and Ventilatory Energy Load and Cerebral Oxygenation During Lumbar Disc Surgery in the Prone Position
This prospective observational study aims to evaluate the relationship between changes in respiratory mechanics and cerebral oxygenation in adult patients undergoing elective lumbar disc surgery in the prone position under general anesthesia.
Cerebral regional oxygen saturation will be monitored using bilateral frontal near-infrared spectroscopy (NIRS), while respiratory parameters including tidal volume, respiratory rate, peak airway pressure, plateau pressure, positive end-expiratory pressure, and dynamic compliance will be recorded from the anesthesia ventilator. Measurements will be obtained at predefined time points before and after positioning the patient prone and after returning to the supine position at the end of surgery.
No changes will be made to anesthesia, ventilation, medication doses, or surgical management for research purposes. All clinical care will be provided according to routine practice by the responsible anesthesia team. The study will investigate whether changes in respiratory mechanics during prone positioning are associated with changes in cerebral regional oxygen saturation.
Read the detailed description
This prospective observational study will evaluate the relationship between respiratory mechanics and cerebral regional oxygen saturation in patients undergoing elective lumbar disc surgery in the prone position under general anesthesia.
Bilateral frontal cerebral oxygen saturation will be monitored using near-infrared spectroscopy (NIRS), and respiratory parameters including tidal volume, respiratory rate, Ppeak, Pplat, PEEP, and dynamic compliance will be recorded at predefined intraoperative time points. No intervention will be made to routine anesthesia, ventilation, medication, or surgical management for research purposes.
- Being tested
- Prone Positioning
- Keywords
- Prone Position, Regional Cerebral Oxygen Saturation, Respiratory Mechanics, Mechanical Power, Lumbar Disc Surgery, Mechanical Ventilation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone PositioningProcedure or surgery
Patients will be placed in the prone position as part of routine surgical care for lumbar disc surgery. The study will observe changes in respiratory mechanics and cerebral regional oxygen saturation before and after prone positioning. No positioning intervention will be assigned or modified for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing Prone Lumbar Disc Surgery | Adult patients undergoing elective lumbar disc herniation surgery in the prone position under general anesthesia. Respiratory mechanics and cerebral regional oxygen saturation will be recorded at predefined intraoperative time points without any research-related modification of routine clinical management. Receives: Procedure: Prone Positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cerebral Regional Oxygen Saturation (rSO2) During Prone Positioning
Bilateral frontal cerebral regional oxygen saturation (rSO2) will be measured using near-infrared spectroscopy (NIRS). Measurements will be recorded at baseline in the supine position (T0), 15 minutes (T1), 30 minutes (T2), 45 minutes (T3), and 60 minutes (T4) after prone positioning, and after return to the supine position at the end of surgery (T5).
Measured: Intraoperative, from baseline before prone positioning to return to the supine position at the end of surgery.
Secondary outcomes (3)
Change in Dynamic Lung Compliance (Cdyn) During Prone Positioning
Dynamic lung compliance (Cdyn) will be recorded from the anesthesia ventilator at predefined intraoperative time points: baseline in the supine position (T0), 15 minutes (T1), 30 minutes (T2), 45 minutes (T3), and 60 minutes (T4) after prone positioning, and after return to the supine position at the end of surgery (T5)
Measured: Intraoperative, from baseline before prone positioning to return to the supine position at the end of surgery.
Change in Peak Airway Pressure (Ppeak) During Prone Positioning
Peak airway pressure (Ppeak) will be recorded from the anesthesia ventilator at T0, T1, T2, T3, T4, and T5 to evaluate changes associated with prone positioning.
Measured: Intraoperative, from baseline before prone positioning to return to the supine position at the end of surgery.
Change in Plateau Pressure (Pplat) During Prone Positioning
Plateau pressure (Pplat) will be recorded from the anesthesia ventilator at T0, T1, T2, T3, T4, and T5 to evaluate changes during prone positioning.
Measured: Intraoperative, from baseline before prone positioning to return to the supine position at the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start9 Sep 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07862257
- Sponsor's protocol ID
- LDH-NIRS-2026
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared with other researchers. Data will be used for the purposes defined in the approved study protocol and handled in accordance with applicable confidentiality and data protection requirements.
Publications
Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
PubMed 27620287Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380.
PubMed 18211991