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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-11
SponsorMarmara University Pendik Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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,

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: intubated patients1 intervention
Group B: group laryngeal mask airway1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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