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Search / Trial NCT06994481

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

Launched by MARMARA UNIVERSITY PENDIK TRAINING AND RESEARCH HOSPITAL · May 20, 2025

Trial Information

Current as of July 21, 2025

Not yet recruiting

Keywords

Optic Nerve Sheath Diameter Pediatric Patients Intubation Laryngeal Mask Airway

ClinConnect Summary

This clinical trial is studying how two types of breathing tubes, called endotracheal intubation and laryngeal masks, affect the optic nerve in children aged 1 to 11 years who are undergoing general anesthesia for surgery. The researchers want to see if using these breathing tubes changes the pressure inside the skull, which can be important for the health of the eyes. The study will use a special ultrasound device to look at the optic nerve, but it won't involve any risky procedures, and nothing will change in how anesthesia is normally given.

To participate in this study, children must be between 1 and 11 years old, be in good health (classified as ASA physical status I or II), and scheduled for surgery requiring general anesthesia with breathing support. Importantly, families can choose not to join the study without affecting their child's treatment, and they can leave the study at any time. All personal information will remain confidential, and there are no costs or payments involved in participating.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Classified as American Society of Anesthesiologists (ASA) physical status I or II,
  • 2. Aged between 1 and 11 years,
  • 3. Scheduled to receive general anesthesia,
  • 4. Planned to be ventilated via endotracheal intubation or laryngeal mask airway (LMA).
  • Exclusion Criteria:
  • 1. Families who do not provide informed consent,
  • 2. Patients with a tracheostomy,
  • 3. History of previous intracranial surgery (e.g., tumor resection or shunt placement),
  • 4. History of preoperative seizures,
  • 5. Presence of craniofacial deformities that may prevent accurate optic nerve sheath diameter (ONSD) measurement,
  • 6. Infection, wound, or any other condition in the measurement area that may interfere with ONSD assessment,
  • 7. Presence of conditions that may increase intracranial pressure and affect ONSD measurement (e.g., tumor, encephalitis, meningitis, or intracranial infection),
  • 8. 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,
  • 9. Patients who withdraw from the study.

About Marmara University Pendik Training And Research Hospital

Marmara University Pendik Training and Research Hospital is a leading healthcare institution in Turkey, dedicated to advancing medical research and education. Affiliated with Marmara University, the hospital serves as a center of excellence for clinical trials, offering state-of-the-art facilities and a multidisciplinary team of experienced healthcare professionals. Committed to improving patient outcomes, the hospital engages in innovative research initiatives that adhere to the highest ethical standards and regulatory compliance, fostering collaboration between academia and clinical practice to enhance therapeutic options and contribute to the global medical community.

Locations

Patients applied

0 patients applied

Trial Officials

tümay umuroglu, professor doctor

Study Director

Marmara University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported