NCT07085949

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

July 17, 2025

Last Update Submit

February 23, 2026

Conditions

Optic Nerve Sheath Diameter

Keywords

Optic nerve sheath diameterIntracranial Pressure Increasespinal surgery

Outcome Measures

Primary Outcomes (1)

  • Optic nerve sheath diameter measurement after extubation

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

    just after extubation

Secondary Outcomes (55)

  • heart rate0

    pre-induction

  • heartrate1

    up to 5 minutes after anesthesia induction

  • heartrate2

    up to 10 minutes after anesthesia induction

  • heartrate3

    up to 15 minutes after anesthesia induction

  • heartrate4

    up to 5 minutes after prone position

  • +50 more secondary outcomes

Study Arms (2)

PEEP 5

5 cmH2O PEEP will be administered during mechanical ventilation

Other: 5 cmH2O PEEP

PEEP 10

10 cmH2O PEEP will be administered during mechanical ventilation

Other: 10 cmH2O PEEP

Interventions

5 cmH2O PEEPOTHER

5 cmH2O PEEP will be administered during mechanical ventilation

PEEP 5
10 cmH2O PEEPOTHER

10 cmH2O PEEP will be administered during mechanical ventilation

PEEP 10

Eligibility Criteria

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

patients undergoing elective

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir City Hospital

Izmir, bayraklı, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Zeki Tuncel Tekgül, Professor

    Izmir City Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor of medicine

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 25, 2025

Study Start

July 30, 2025

Primary Completion

January 1, 2026

Study Completion

January 2, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

TU(1)