The Effect Of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter In Pediatric Patients Undergoing Craniotomy in Supine Position

January 20, 2026 updated by: Eren Karahan, Dr. Lutfi Kirdar Kartal Training and Research Hospital
This study evaluated the effect of positive end-expiratory pressure (PEEP) on optic nerve sheath diameter (ONSD), an indicator of intracranial pressure, in pediatric patients undergoing craniotomy in the supine position. The findings indicated that the application of PEEP did not result in a significant difference in ONSD. Although a significant decrease in systolic and diastolic blood pressure was observed with the use of PEEP, these values remained within normal ranges and did not indicate adverse hemodynamic effects. The results suggest that the use of a PEEP level of 4 cmH2O in pediatric patients with intracranial masses is safe and may be applied during the perioperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • eyüpsultan
      • Istanbul, eyüpsultan, Turkey (Türkiye), 34077
        • Dr Lutfi Kırdar City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pediatric patients aged 6 months to 18 years
  • American Society of Anesthesiologists (ASA) physical status III
  • Scheduled for elective craniotomy in the supine position
  • Presence of an extra-axial intracranial mass
  • Written informed consent obtained from parents or legal guardians

Exclusion Criteria:

  • Open fontanelles
  • Orbital pathology
  • Severe increases in intracranial pressure associated with nausea, vomiting, visual disturbances, or seizures
  • Radiologic or clinical signs of brain herniation
  • Hydrocephalus
  • Cerebral infection
  • Congenital syndromes
  • History of surgery involving the optic nerve
  • Use of inotropic therapy
  • Hemodynamic instability
  • Surgical complications during the operation or procedures lasting longer than 8 hours
  • Postoperative intubation requiring intensive care unit follow-up
  • Tumors invading the optic nerve
  • Inability to obtain written informed consent from parents or legal guardians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study Group
PEEP 4 group
Drug: General Anesthesia
General anesthesia was administered according to standard clinical practice, including intravenous induction agents and inhalational anesthetics, as part of routine perioperative care.
Drug: Anesthetic Agents
Anesthetic agents, including propofol, fentanyl, rocuronium, and sevoflurane, were used as part of standard anesthetic management during the procedure.
Device: mechanical ventilation (MV)
Mechanical ventilation was provided using a standard anesthesia ventilator in volume-controlled mode during surgery.
Active Comparator: Control Group
PEEP 0 Group
Drug: General Anesthesia
General anesthesia was administered according to standard clinical practice, including intravenous induction agents and inhalational anesthetics, as part of routine perioperative care.
Drug: Anesthetic Agents
Anesthetic agents, including propofol, fentanyl, rocuronium, and sevoflurane, were used as part of standard anesthetic management during the procedure.
Device: mechanical ventilation (MV)
Mechanical ventilation was provided using a standard anesthesia ventilator in volume-controlled mode during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
optic nerve sheath diameter
Time Frame: Four times in during the operation by using ultrasonography. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation
Four times in during the operation by using ultrasonography. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart Rate
Time Frame: Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation
Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation
systolic blood pressure
Time Frame: Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation
Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation
diastolic blood pressure
Time Frame: Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation
Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation
Peripheral oxygen saturation
Time Frame: Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation
Four times in during the operation. T0: before induction of anesthesia; T1: immediately after the dura was opened; T2: just before the dura was closed; T3: before extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

October 30, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LutfiKırdarCityHospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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