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Optic Nerve Sheath Diameter in Pediatric Patients

Primary Purpose

Optic Nerve Sheath Neoplasm, Intracranial Pressure Increase, Intubation Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optic nerve sheath diameter measurement with linear ultrasound
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Optic Nerve Sheath Neoplasm

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Group 3

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Optic nerve sheath diameter measurement at pediatric patients
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 29, 2022
    Last Updated
    July 4, 2022
    Sponsor
    Kahramanmaras Sutcu Imam University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05445271
    Brief Title
    Optic Nerve Sheath Diameter in Pediatric Patients
    Official Title
    The Effects of Endotracheal Intubation or Laryngeal Mask Applications on Optic Nerve
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kahramanmaras Sutcu Imam University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Optic Nerve Sheath Neoplasm, Intracranial Pressure Increase, Intubation Complication, Airway Complication of Anesthesia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Group 3
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Optic nerve sheath diameter measurement with linear ultrasound
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Optic nerve sheath diameter measurement at pediatric patients
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients aged 2-18 years Patients undergoing general anesthesia Patients who agreed to be included ASA I-III Exclusion Criteria: Those with any eye pathology Those with intracranial pathology
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Feyza Calisir
    Phone
    05056492875
    Email
    fbolcal@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Optic Nerve Sheath Diameter in Pediatric Patients

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