Comparison of the Effects of Endotracheal Intubation and Laryngeal Mask Applications on Optic Ner… (NCT06994481) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of the Effects of Endotracheal Intubation and Laryngeal Mask Applications on Optic Nerve Diameter in Pediatric Patients
200 participantsStarted 2025-06-01
Plain-language summary
This clinical study aims to investigate the effects of breathing tubes, which we use to connect children aged 1-11 to a respiratory device under general anesthesia in the operating room, on intracranial pressure after they are inserted. No changes will be made to routine anesthesia practices for this purpose, and eye examinations will be performed with an USG device. This study has no undesirable effects or risks. This study does not include any invasive procedures. You have the right to refuse to participate in the study. You have the right to withdraw from the study at any time. If you decide not to participate in the study for any reason, there will be no disruption to your treatment. You will not be liable for any financial loss if you participate in the study, and you will not be paid. Your identity will be kept confidential if you participate in the study.
Who can participate
Age range
1 Year – 11 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
. Classified as American Society of Anesthesiologists (ASA) physical status I or II,
. Aged between 1 and 11 years,
. Scheduled to receive general anesthesia,
. Planned to be ventilated via endotracheal intubation or laryngeal mask airway (LMA).
Exclusion criteria
. Families who do not provide informed consent,
. Patients with a tracheostomy,
. History of previous intracranial surgery (e.g., tumor resection or shunt placement),
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 sheet diameter measurement
Timeframe: (TO) immediately after anesthesia induction, (T1) within a few minutes after endotracheal intubation / LMA insertion, (T2) immediately after extubation.
Trial details
NCT IDNCT06994481
SponsorMarmara University Pendik Training and Research Hospital
. Presence of craniofacial deformities that may prevent accurate optic nerve sheath diameter (ONSD) measurement,
. Infection, wound, or any other condition in the measurement area that may interfere with ONSD assessment,
. Presence of conditions that may increase intracranial pressure and affect ONSD measurement (e.g., tumor, encephalitis, meningitis, or intracranial infection),
. Patients who require a change in the endotracheal tube or laryngeal mask airway (LMA) size during the operation, or who undergo a second intubation or insertion attempt,