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NCT06994481

Comparison of the Effects of Endotracheal Intubation and Laryngeal Mask Applications on Optic Nerve Diameter in Pediatric Patients

Sponsor: Marmara University Pendik Training and Research Hospital

View on ClinicalTrials.gov

Summary

This clinical study aims to investigate the effects of breathing tubes - used 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 ultrasound (USG) device. This study has no undesirable effects or risks. This study does not include any invasive procedures. Participants have the right to refuse to take part in the study. Participants have the right to withdraw from the study at any time. If a participant decides not to take part in the study for any reason, there will be no disruption to that participant's treatment. Participants will not incur any financial loss by taking part in the study and will not be paid. Each participant's identity will be kept confidential throughout participation in the study.

Key Details

Gender

All

Age Range

1 Year - 11 Years

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2025-09-01

Completion Date

2026-08-01

Last Updated

2026-10-07

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

optic nerve sheet diameter measurement

Optic nerve sheath diameter will be measured noninvasively using a 6-13 MHz linear ultrasound probe placed gently over the closed upper eyelid without applying pressure to the globe. Measurements will be obtained 3 mm posterior to the globe in both eyes at three predefined time points: T0: Immediately after induction of general anesthesia and before airway device placement T1: Within the first few minutes after endotracheal tube or laryngeal mask airway placement T2: Immediately after removal of the airway device at the end of anesthesia Mean arterial pressure and end-tidal carbon dioxide values will be recorded simultaneously.

Locations (1)

Marmara University Pendik Eğitim Ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)