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NCT05445271 Clinical Trial

Optic Nerve Sheath Diameter in Pediatric Patients

Intubation Complication Clinical Trial

Official title:
The Effects of Endotracheal Intubation or Laryngeal Mask Applications on Optic Nerve

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05445271
Other study ID # 2018/01-28
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2022

Study information
Verified date July 2022
Source Kahramanmaras Sutcu Imam University
Contact Feyza Calisir
Phone 05056492875
Email fbolcal@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 90
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 6 months
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