Status:
NOT_YET_RECRUITING
Comparison of the Effects of Endotracheal Intubation and Laryngeal Mask Applications on Optic Nerve Diameter in Pediatric Patients
Lead Sponsor:
Marmara University Pendik Training and Research Hospital
Conditions:
Optic Nerve Sheath Diameter
Pediatric Anesthesia
Eligibility:
All Genders
1-11 years
Brief 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 intracrani...
Detailed Description
Our study will be conducted in the Marmara University Basibüyük Additional Service Building Prof. Dr. Asaf Ataseven Hospital Operating Room, on 200 ASA 1-2 (American Society of Anesthesiologists) chil...
Eligibility Criteria
Inclusion
- 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
- 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,
- 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,
- Patients who withdraw from the study.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06994481
Start Date
June 1 2025
End Date
June 1 2026
Last Update
May 29 2025
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