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 range1 Year – 11 Years
SexALL
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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),
✕. History of preoperative seizures,
✕. 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,
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 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,