Skip to main content
OpenTrials
Completed

NCT Number: NCT07085949

Effect of Different Positive End-Expiratory Pressure (PEEP) Levels on Optic Nerve Sheath Diameter

The goal of this prospective observational study is to evaluate the effects of different PEEP values on the optic nerve sheath diameter (ONSD), a noninvasive indicator of intracranial pressure (ICP), in patients undergoing vertebral surgery. The main question it aims to answer is how mechanical ventilation setting of 5 and 10 cmH2O PEEP effect optic nerve sheath diameter after surgery at extubation.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir City Hospital

Izmir, bayraklı, 35100, Turkey (Türkiye)

About this study

During general anesthesia, endotracheal intubation can cause varying degrees of alveolar collapse, particularly in the lower lung regions, in 15-20% of cases. Postoperative atelectasis and pulmonary infections are responsible for both prolonged hospital stays and increased mortality and morbidity. Positive end-expiratory pressure (PEEP) combined with low tidal volume, defined as lung-protective ventilation strategies, is used in anesthesia practice because it prevents pulmonary barotrauma, improves pulmonary function, and reduces postoperative pulmonary complications. PEEP can prevent atelectasis and reduce the risk of ventilator-associated lung injury. PEEP at 10 cmH2O or less can be used without causing a significant increase in intracranial pressure or a significant decrease in cerebral perfusion pressure.

For years, low PEEP was used in neurosurgery and neurosurgical intensive care patients, considering that PEEP could increase ICP. However, recent studies in normovolemic patients without hypotension have shown that even with increased PEEP, no clinically significant increase in ICP was observed.

The optic nerve is anatomically an extension of the central nervous system. Cerebrospinal fluid (CSF) circulates within this extension, which is surrounded by dura mater. Therefore, noninvasive ultrasonographic measurement of optic nerve sheath diameter (ONSD) has been shown to be effective in detecting increased intracranial pressure (ICP) due to the reflection of changes in subarachnoid space pressure and CSF on the optic nerve sheath. An optic nerve sheath diameter greater than 6 mm is a noninvasive indicator of increased intracranial pressure.

The effect of positive end-expiratory pressure (PEEP) on optic nerve sheath diameter in patients undergoing vertebral surgery will be evaluated.

Optic nerve sheath diameter measurements will be taken twice with ultrasound, once before surgery in the preoperative waiting room and once after surgery in the postoperative recovery unit.

Hemodynamic data (systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate, peripheral oxygen saturation), and PEEP values during anesthesia will be recorded on the anesthesia observation form.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18-65 years
  • ASA I, II, III
  • Patients undergoing elective vertebral surgery in the prone position

Exclusion criteria

  • Patients were defined as having a hemoglobin concentration below 9 g/dL
  • Congestive heart failure
  • Uncontrolled hypertension
  • Severe COPD
  • Pulmonary edema
  • Cerebrovascular disease
  • Those who have had carotid stenosis or surgery
  • Hemodynamic instability
  • Pregnant women
  • Those who did not wish to participate in the study.

Treatment and study plan

5 cmH2O PEEP

Other

5 cmH2O PEEP will be administered during mechanical ventilation

10 cmH2O PEEP

Other

10 cmH2O PEEP will be administered during mechanical ventilation

Primary outcomes

  1. Optic nerve sheath diameter measurement after extubation

    Time frame: just after extubation

    optic nerve sheath diameter will be measured at the end of the surgery after extubation

Secondary outcomes

  1. heart rate0

    Time frame: pre-induction

  2. heartrate1

    Time frame: up to 5 minutes after anesthesia induction

  3. heartrate2

    Time frame: up to 10 minutes after anesthesia induction

  4. heartrate3

    Time frame: up to 15 minutes after anesthesia induction

  5. heartrate4

    Time frame: up to 5 minutes after prone position

  6. heartrate5

    Time frame: up to 10 minutes after prone position

  7. heartrate6

    Time frame: up to 15 minutes after prone position

  8. heartrate7

    Time frame: up to 30 minutes after prone position

  9. heartrate8

    Time frame: up to 1 hour after prone position

  10. heartrate9

    Time frame: up to 2 hour after prone position

  11. heartrate10

    Time frame: up to 3 hour after prone position

  12. mean arterial pressures0

    Time frame: pre induction

  13. mean arterial pressures1

    Time frame: up to 5 minutes after anesthesia

  14. mean arterial pressures2

    Time frame: up to 10 minutes after anesthesia induction

  15. mean arterial pressures3

    Time frame: up to 15 minutes after anesthesia induction

  16. mean arterial pressures4

    Time frame: up to 5 minutes after prone position

  17. mean arterial pressures5

    Time frame: up to 10 minutes after prone position

  18. mean arterial pressures6

    Time frame: up to 15 minutes after prone position

  19. meanarterialpressures7

    Time frame: up to 30 minutes after prone position

  20. meanarterialpressures8

    Time frame: up to 1 hour after prone position

  21. meanarterialpressures9

    Time frame: 2 hour after prone position

  22. meanarterialpressures10

    Time frame: 3 hour after prone position

  23. diastolicpressures0

    Time frame: pre induction

  24. diastolicpressures1

    Time frame: up to 5 minutes after anesthesia induction

  25. diastolicpressures2

    Time frame: up to 10 minutes after anesthesia indüction

  26. diastolicpressures3

    Time frame: up to 15 minutes after anesthesia induction

  27. diastolicpressures4

    Time frame: up to 5 minutes after prone position

  28. diastolicpressures5

    Time frame: up to 10 minutes after prone position

  29. diastolicpressures6

    Time frame: up to 15 minutes after prone position

  30. diastolicpressures7

    Time frame: up to 30 minutes after prone position

  31. diastolicpressures8

    Time frame: up to 1 hour after prone position

  32. diastolicpressures9

    Time frame: up to 2 hour after prone position

  33. diastolicpressures10

    Time frame: up to 3 hour after prone position

  34. systolicpressures0

    Time frame: pre-induction

  35. systolicpressure1

    Time frame: up to 5 minutes after anesthesia

  36. systolicpressure2

    Time frame: up to 10 minutes after anesthesia

  37. systolicpressure3

    Time frame: up to 15 minutes after anesthesia

  38. systolicpressure4

    Time frame: up to 5 minutes after prone position

  39. systolicpressure5

    Time frame: up to 10 minutes after prone position

  40. systolicpressure6

    Time frame: up to 15 minutes after prone position

  41. systolicpressure7

    Time frame: up to 30 minutes after prone position

  42. systolicpressure8

    Time frame: up to 1 hour after prone position

  43. systolicpressure9

    Time frame: up to 2 hour after prone position

  44. systolicpressure10

    Time frame: up to 3 hour after prone position

  45. peripheral oxygen saturation (SpO₂)0

    Time frame: pre-ınduction

  46. peripheral oxygen saturation (SpO₂)1

    Time frame: up to 5 minutes after anesthesia induction

  47. peripheral oxygen saturation (SpO₂)2

    Time frame: up to 10 minutes after anesthesia induction

  48. peripheral oxygen saturation (SpO₂)3

    Time frame: up to 15 minutes after anesthesia induction

  49. peripheral oxygen saturation (SpO₂)4

    Time frame: up to 5 minutes after prone position

  50. peripheral oxygen saturation (SpO₂)5

    Time frame: up to 10 minutes after prone position

  51. peripheral oxygen saturation (SpO₂)6

    Time frame: up to 15 minutes after prone position

  52. peripheral oxygen saturation (SpO₂)7

    Time frame: up to 30 minutes after prone position

  53. peripheral oxygen saturation (SpO₂)8

    Time frame: up to 1 hour after prone position

  54. peripheral oxygen saturation (SpO₂)9

    Time frame: up to 2 hour after prone position

  55. peripheral oxygen saturation (SpO₂)10

    Time frame: up to 3 hour after prone position

Sponsors and collaborators

Lead sponsor

Izmir City Hospital

Other Gov

Registry information

Official study title

Evaluation of the Effect of Different Positive End-Expiratory Pressure (PEEP) Levels on Optic Nerve Sheath Diameter in Patients Undergoing Vertebral Surgery; Prospective Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.