Craniotomy SurgeryNCT07370779
The Effect Of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter In Pediatric Patients Undergoing Craniotomy in Supine Position
A study testing General Anesthesia, Anesthetic Agents and mechanical ventilation (MV) in people with Craniotomy Surgery and Pediatric Patient Safety, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Craniotomy Surgery, Pediatric Patient Safety, Pediatric Patient
- What is being tested?
- General Anesthesia, Anesthetic Agents and mechanical ventilation (MV)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr Lutfi Kırdar City Hospital
Istanbul, eyüpsultan, 34077
About this study
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.
- Conditions
- Craniotomy Surgery, Pediatric Patient Safety, Pediatric Patient, Positive End-expiratory Pressure (PEEP), Optic Nerve Sheath Diameter Measurement
- Being tested
- General Anesthesia, Anesthetic Agents, mechanical ventilation (MV)
- Keywords
- peep, pediatric patients, optic nerve sheath diameter, intracranial pressure, craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaDrug
General anesthesia was administered according to standard clinical practice, including intravenous induction agents and inhalational anesthetics, as part of routine perioperative care.
Anesthetic AgentsDrug
Anesthetic agents, including propofol, fentanyl, rocuronium, and sevoflurane, were used as part of standard anesthetic management during the procedure.
mechanical ventilation (MV)Device
Mechanical ventilation was provided using a standard anesthesia ventilator in volume-controlled mode during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | PEEP 4 group Receives: Drug: General Anesthesia; Drug: Anesthetic Agents; Device: mechanical ventilation (MV) |
| Control Group | Active comparator | PEEP 0 Group Receives: Drug: General Anesthesia; Drug: Anesthetic Agents; Device: mechanical ventilation (MV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter
Measured: 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 outcomes (4)
Heart Rate
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Jan 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Craniotomy SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The initial group (Study Group) received a PEEP level of 4 cmH2O. Tthe second group (Control Group) received no PEEP.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eren Karahan, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370779
- Sponsor's protocol ID
- LutfiKırdarCityHospital
- Status last verified
- Jan 2026
- First submitted
- 20 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sezen O, Saracoglu KT, Simsek T, Cevik B, Aydogmus E. The effect of positive end-expiratory pressure on optic nerve diameter in patients undergoing craniotomy operation. Ann Clin Anal Med. 2021;12(02):199-203.
Pulitano S, Mancino A, Pietrini D, Piastra M, De Rosa S, Tosi F, De Luca D, Conti G. Effects of positive end expiratory pressure (PEEP) on intracranial and cerebral perfusion pressure in pediatric neurosurgical patients. J Neurosurg Anesthesiol. 2013 Jul;25(3):330-4. doi: 10.1097/ANA.0b013e31828bac4d.
PubMed 23519374Padayachy L, Brekken R, Fieggen G, Selbekk T. Noninvasive Transorbital Assessment of the Optic Nerve Sheath in Children: Relationship Between Optic Nerve Sheath Diameter, Deformability Index, and Intracranial Pressure. Oper Neurosurg. 2019 Jun 1;16(6):726-733. doi: 10.1093/ons/opy231.
PubMed 30169680Khandelwal A, Kapoor I, Mahajan C, Prabhakar H. Effect of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter in Pediatric Patients with Traumatic Brain Injury. J Pediatr Neurosci. 2018 Apr-Jun;13(2):165-169. doi: 10.4103/jpn.JPN_112_17.
PubMed 30090129
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter In Pediatric Patients Undergoing Craniotomy in Supine Position
- ClinicalTrials.gov ID
- NCT07370779
- Acronym / sponsor ID
- LutfiKırdarCityHospital
- Conditions
- Craniotomy Surgery, Pediatric Patient Safety, Pediatric Patient, Positive End-expiratory Pressure (PEEP), Optic Nerve Sheath Diameter Measurement
- Keywords
- peep, pediatric patients, optic nerve sheath diameter, intracranial pressure, craniotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The initial group (Study Group) received a PEEP level of 4 cmH2O. Tthe second group (Control Group) received no PEEP.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Drug: General Anesthesia, Drug: Anesthetic Agents, Device: mechanical ventilation (MV)PEEP 4 group |
| Control Group | Active comparator | Drug: General Anesthesia, Drug: Anesthetic Agents, Device: mechanical ventilation (MV)PEEP 0 Group |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General AnesthesiaGeneral anesthesia was administered according to standard clinical practice, including intravenous induction agents and inhalational anesthetics, as part of routine perioperative care. | Drug | Control Group, Study Group |
| Anesthetic AgentsAnesthetic agents, including propofol, fentanyl, rocuronium, and sevoflurane, were used as part of standard anesthetic management during the procedure. | Drug | Control Group, Study Group |
| mechanical ventilation (MV)Mechanical ventilation was provided using a standard anesthesia ventilator in volume-controlled mode during surgery. | Device | Control Group, Study Group |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- BackgroundSezen O, Saracoglu KT, Simsek T, Cevik B, Aydogmus E. The effect of positive end-expiratory pressure on optic nerve diameter in patients undergoing craniotomy operation. Ann Clin Anal Med. 2021;12(02):199-203.
- Background: PubMed 23519374Pulitano S, Mancino A, Pietrini D, Piastra M, De Rosa S, Tosi F, De Luca D, Conti G. Effects of positive end expiratory pressure (PEEP) on intracranial and cerebral perfusion pressure in pediatric neurosurgical patients. J Neurosurg Anesthesiol. 2013 Jul;25(3):330-4. doi: 10.1097/ANA.0b013e31828bac4d.
- Background: PubMed 30169680Padayachy L, Brekken R, Fieggen G, Selbekk T. Noninvasive Transorbital Assessment of the Optic Nerve Sheath in Children: Relationship Between Optic Nerve Sheath Diameter, Deformability Index, and Intracranial Pressure. Oper Neurosurg. 2019 Jun 1;16(6):726-733. doi: 10.1093/ons/opy231.
- Background: PubMed 30090129Khandelwal A, Kapoor I, Mahajan C, Prabhakar H. Effect of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter in Pediatric Patients with Traumatic Brain Injury. J Pediatr Neurosci. 2018 Apr-Jun;13(2):165-169. doi: 10.4103/jpn.JPN_112_17.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anesthesia, Anesthetic Agents and mechanical ventilation (MV) in people with Craniotomy Surgery and Pediatric Patient Safety, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07370779, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.