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临床试验/NCT06830460
NCT06830460尚未招募不适用

Efficacy of a Theoretical-practical Course for the Ultrasound Measurement of the Optic Nerve Diameter in Different Healthcare Operators

University Magna Graecia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
OSND measure affidability

研究概览

简要总结

The study evaluates the effectiveness of a theoretical-practical training course for the ultrasound measurement of the optic nerve sheath diameter (ONSD), a non-invasive method used to estimate intracranial pressure (ICP). The optic nerve sheath is continuous with the subarachnoid space, which contains cerebrospinal fluid (CSF). An increase in ICP leads to an increase in CSF within the sheath, enlarging its diameter. ONSD measurement is typically performed by placing an ultrasound probe on the closed eyelid, allowing visualization of the optic nerve behind the eyeball.

While the correlation between ONSD enlargement and elevated ICP is well-documented, there is variability in diagnostic cut-off values due to differences in measurement techniques, equipment, and operator experience. Previous studies have shown that even novice operators can achieve clinically acceptable accuracy after brief training.

This study aims to assess whether medical students, nursing students, anesthesiology and intensive care residents, and intensive care nurses can learn to perform reliable ONSD measurements after a short training session.

Methodology:

The study will involve 40 participants unfamiliar with ONSD measurement: 10 medical students, 10 nursing students, 10 anesthesiology and intensive care residents, and 10 experienced intensive care nurses. The training will consist of a four-hour session, including a 30-minute lecture on ocular anatomy and ultrasound techniques, a real-time demonstration, and supervised hands-on practice with at least 20 measurements.

Participants must pass a multiple-choice test with at least 70% correct answers to proceed to practical verification, where they will measure ONSD in five healthy volunteers. These measurements will be compared with those taken by an expert tutor.

Measurement Technique:

The ultrasound technique follows expert consensus guidelines, using a linear probe with a minimum frequency of 7.5 MHz. Volunteers will be positioned semi-seated at a 45° head elevation with closed eyelids. The ONSD measurement will be taken 3 mm behind the retina on the right eye. Care will be taken to avoid pressure on the eyeball, and safety parameters will be monitored to ensure compliance with FDA guidelines.

The study aims to demonstrate that various healthcare professionals can achieve accurate and reliable ONSD measurements with proper training, enhancing the utility of this technique in diverse clinical settings.

详细描述

INTRODUCTION The measurement of the optic nerve sheath diameter (ONSD) is a non-invasive diagnostic technique used to estimate intracranial pressure (ICP). The optic nerve sheath, which surrounds the optic nerve, is continuous with the subarachnoid space, which contains cerebrospinal fluid (CSF). When ICP increases, the amount of cerebrospinal fluid in the optic nerve sheath also increases, causing an enlargement of its diameter.

The measurement of ONSD is performed non-invasively using ultrasound by placing an ultrasound probe on the closed eyelid to visualize the optic nerve behind the eyeball [3]. Guidelines on how to measure ONSD have recently been published in a statement by an international consensus of experts.

The correlation between increased ONSD and elevated ICP is well documented. An ONSD exceeding reference values can indicate elevated intracranial pressure. Although it is not a continuous monitoring method, ONSD measurement can be performed repeatedly at the patient's bedside and in remote locations without causing significant discomfort to the operator or patient, which may be invaluable for patient triage and management. It can also be useful for the continuous assessment of critically ill patients in tertiary care centers, especially those too unstable to be transported to the radiology department for a CT scan or MRI.

The diagnostic cut-off values indicating elevated ICP vary across studies and meta-analyses. Generally, reported values range between 4.8 mm and 6.4 mm. This variability is influenced by several factors, including measurement techniques, equipment used, and operator experience.

To date, no clear and direct data demonstrate that healthcare professionals other than medical specialists (with varying levels of expertise) can learn this technique and obtain reliable ONSD measurements. Therefore, we designed this study to assess the ability of medical students, nursing students, anesthesiology and intensive care residents, and intensive care nurses to visualize and correctly measure ONSD in healthy volunteers after a brief training course on the technique.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •medical student, or nurse student, or residents in anesthesia or nurse with at least 3 years of Intensive care unit experience

排除标准

  • •previous skills on ONSD measurements

研究组 & 干预措施

ONSD training

Experimental

干预措施: Training (Other)

结局指标

主要结局

OSND measure affidability

时间窗: Through study completion, an average of 3 hours

ONSD measure will be recorded and compared to that one from a expert tutor

次要结局

未报告次要终点

研究者

发起方
University Magna Graecia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Longhini

Associate Professor in Anesthesia and Intensive Care Medicine

University Magna Graecia

研究点 (1)

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