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

StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Start date changed from estimate of Jun 1, 2025 to Sep 1, 2025 Show 7 more changesShow less
    • Completed without a posted recruiting period
    • Final enrollment: 160 participants (planned 200)
    • Primary completion date changed from estimate of Mar 1, 2026 to Aug 1, 2026
    • Trial arms changed: 2 → 4
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 13 words
    • Study description expanded, about 7 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06994481
Lead Sponsor Marmara University Pendik Training and Research Hospital
Conditions
(from sponsor)		 Optic Nerve Sheath Diameter, Pediatric Anesthesia, Intubation, Laryngeal Mask Airways
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov