Optic Nerve Sheath Diameter in Pediatric Patients

Kahramanmaraş Sütçü İmam University (KSU)

Status: Not yet enrolling

Conditions: Intracranial Pressure Increase; Airway Complication of Anesthesia; Optic Nerve Sheath Neoplasm; Intubation Complication

Treatments: Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05445271

2018/01-28

Details and patient eligibility

About

Endotracheal intubation and laryngeal mask are generally applied to secure the airway during general anesthesia. There is a widespread opinion among anesthesiologists that endotracheal intubation increases intracranial pressure. Since there were no non-invasive methods measuring intracranial pressure in the past, adequate studies on this subject could not be done. With this measurement, we aimed to show whether ETT or LMA applications have effects on intracranial pressure.

Full description

In normal pediatric patients with closed fontanelles, the contents of the central nervous system are almost compressed into the skull and spinal canal. Intracranial pressure is created and constant by the total volume of brain, CSF, and blood within the skull. Increased intracranial pressure can be measured with an intraventricular catheter, transducers, and a subarachnoid bolt. By measuring the diameter of the optic nerve sheath with ultrasonography, we can find out whether there is an increase in intracranial pressure non-invasively.

Endotracheal intubation and laryngeal mask are generally applied to secure the airway during general anesthesia. There is a widespread opinion among anesthesiologists that endotracheal intubation increases intracranial pressure. Since there were no non-invasive methods measuring intracranial pressure in the past, adequate studies on this subject could not be done. With this measurement, we aimed to show whether ETT or LMA applications have effects on intracranial pressure.

Enrollment: 90 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients aged 2-18 years
2. Patients undergoing general anesthesia
3. Patients who agreed to be included
4. ASA I-III

Exclusion criteria

1. Those with any eye pathology
2. Those with intracranial pathology

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Group 1

Active Comparator group

Description:

30 patients who will be intubated with a video laryngoscope and who meet the inclusion criteria are randomly selected by lottery method. After obtaining the consent of the patient's family, the patient is taken to the operating room and monitored. 5 minutes after sedation with 1 mg midazolam, the optic nerve sheath diameter of both eyes is measured with a linear ultrasound probe and recorded (T0). 5 minutes after the patient is intubated with a video laryngoscope, the optic nerve sheath diameter of both eyes is measured and recorded (T1). After the patient's extubation at the end of the case, the optic nerve sheath diameter of both eyes is measured and recorded (T2). Vitals (pulse, blood pressure, saturation) involved in T0, T1 and T2 processes are recorded.

Treatment:

Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound

Group 2

Active Comparator group

Description:

30 patients who will be intubated with a normal laryngoscope and who meet the inclusion criteria are randomly selected by lottery method. After obtaining the consent of the patient's family, the patient is taken to the operating room and monitored. 5 minutes after sedation with 1 mg midazolam, the optic nerve sheath diameter of both eyes is measured with a linear ultrasound probe and recorded (T0). 5 minutes after the patient is intubated with a normal laryngoscope, the optic nerve sheath diameter of both eyes is measured and recorded (T1). After the patient's extubation at the end of the case, the optic nerve sheath diameter of both eyes is measured and recorded (T2). Vitals (pulse, blood pressure, saturation) involved in T0, T1 and T2 processes are recorded.

Treatment:

Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound

Group 3

Active Comparator group

Description:

30 patients who will be ventilated with a laryngeal mask airway (LMA) and who meet the inclusion criteria are randomly selected by lottery method. After obtaining the consent of the patient's family, the patient is taken to the operating room and monitored. 5 minutes after sedation with 1 mg midazolam, the optic nerve sheath diameter of both eyes is measured with a linear ultrasound probe and recorded (T0). The optic nerve sheath diameter of both eyes is measured and recorded 5 minutes after LMA is placed on the patient (T1). After the patient's extubation at the end of the case, the optic nerve sheath diameter of both eyes is measured and recorded (T2). Vitals (pulse, blood pressure, saturation) involved in T0, T1 and T2 processes are recorded.

Treatment:

Diagnostic Test: Optic nerve sheath diameter measurement with linear ultrasound