The Effect Of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter In Pediatric Patien… (NCT07370779) | Clinical Trial Compass
CompletedNot Applicable
The Effect Of Positive End-Expiratory Pressure on Optic Nerve Sheath Diameter In Pediatric Patients Undergoing Craniotomy in Supine Position
Turkey (Türkiye)30 participantsStarted 2021-01-01
Plain-language 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. 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.
Who can participate
Age range
6 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
optic nerve sheath diameter
Timeframe: 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
Trial details
NCT IDNCT07370779
SponsorDr. Lutfi Kirdar Kartal Training and Research Hospital