Optic Nerve Sheath Diameter in Pediatric Patients

NCT ID: NCT05445271

Last Updated: 2022-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

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.

Group Type ACTIVE_COMPARATOR

Optic nerve sheath diameter measurement with linear ultrasound

Intervention Type DIAGNOSTIC_TEST

In this study, we aimed to show whether endotracheal intubation or LMA applications with optic nerve sheath diameter measurement, which is a completely non-invasive method, have effects on intracranial pressure.

Group 2

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.

Group Type ACTIVE_COMPARATOR

Optic nerve sheath diameter measurement with linear ultrasound

Intervention Type DIAGNOSTIC_TEST

In this study, we aimed to show whether endotracheal intubation or LMA applications with optic nerve sheath diameter measurement, which is a completely non-invasive method, have effects on intracranial pressure.

Group 3

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.

Group Type ACTIVE_COMPARATOR

Optic nerve sheath diameter measurement with linear ultrasound

Intervention Type DIAGNOSTIC_TEST

In this study, we aimed to show whether endotracheal intubation or LMA applications with optic nerve sheath diameter measurement, which is a completely non-invasive method, have effects on intracranial pressure.

Interventions

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Optic nerve sheath diameter measurement with linear ultrasound

In this study, we aimed to show whether endotracheal intubation or LMA applications with optic nerve sheath diameter measurement, which is a completely non-invasive method, have effects on intracranial pressure.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Feyza Calisir

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Feyza Calisir

Role: CONTACT

05056492875

Other Identifiers

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2018/01-28

Identifier Type: -

Identifier Source: org_study_id

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