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

NCT06994481 | Not Yet Recruiting

• 1 other identifier: marmaraeah1
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Optic Nerve Sheath Diameter; Pediatric Anesthesia; Intubation; Laryngeal Mask Airways

Keywords

optic nerve sheath diameter; pediatric patients; intubation; laryngeal mask airway

Outcome Measures

Primary Outcomes (1)

• optic nerve sheet diameter measurement

  For sonographic measurements, a linear 6-13 Hz probe (Fujifilm Sonosite, Bothwell, USA) will be used at three different time points. The probe will be carefully moved to find the best image of the optic nerve entering the globe, and ONSD (optic nerve sheath diameter) will be measured 3 mm posterior to the globe. These measurements will be taken at 3 times: (TO) immediately after anesthesia induction, (T1) within a few minutes after endotracheal intubation / LMA insertion, and (T2) immediately after extubation. At the specified times, ultrasonographic measurements will be made and recorded by 2 different individuals who have received USG training and who have previously measured the optic nerve sheath diameter. Mean arterial pressure and EtCO2 values will also be recorded simultaneously.

  (TO) immediately after anesthesia induction, (T1) within a few minutes after endotracheal intubation / LMA insertion, (T2) immediately after extubation.

Study Arms (2)

intubated patients

Patients aged 1-11 years who are scheduled for elective surgery and undergo endotracheal intubation

Diagnostic Test: optic nerve sheet diameter measurement

group laryngeal mask airway

Patients aged 1-11 years who are scheduled for elective surgery and who use supraglottic airway devices

Diagnostic Test: optic nerve sheet diameter measurement

Interventions

optic nerve sheet diameter measurement DIAGNOSTIC_TEST

Both groups will undergo bilateral optic nerve sheath diameter measurement with ultrasonography after induction, after airway manipulations, and before awakening.

group laryngeal mask airway; intubated patients

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

ASA I-II children aged 1-11 years who are planned to receive general anesthesia, intubation or LMA insertion will be included in the study.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Officials

• tümay umuroglu, professor doctor

  Marmara University

  STUDY DIRECTOR

Central Study Contacts

Feyza Özaltun özaltun, M.D.

CONTACT

+90 5056884219; feyzametin@yahoo.com.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dilara göçmen

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL