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临床试验/CTRI/2025/08/093087
CTRI/2025/08/093087尚未招募不适用

Correlation of ultrasound guided pupillary and optic nerve sheath diameter with GCS in patients with altered mental status in the emergency.

Akshay S Suresh1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
149
试验地点
1
主要终点
Correlation between pupillary diameter measured by ultrasound with Glasgow Coma Scale score in patients presenting with altered mental status in the emergency department.

研究概览

简要总结

This cross-sectional observational study aims to evaluate the correlation of ultrasound-measured pupillary diameter and optic nerve sheath diameter (ONSD) with the Glasgow Coma Scale (GCS) in patients presenting with altered mental status (AMS) to the Emergency Department of ABVIMS & Dr. RML Hospital, New Delhi. A total of 149 adult patients will be enrolled over a period of one year following approval from the Institutional Ethics Committee. Patients will be selected based on predefined inclusion and exclusion criteria and evaluated within 6 hours of presentation.

Following clinical assessment and GCS scoring, a standardized Point-of-Care Ultrasound (POCUS) technique will be used to measure bilateral ONSD and pupillary diameter. For each parameter, three measurements per eye will be recorded, and the mean value will be used for analysis. Data including patient demographics, clinical history, GCS, and ultrasound findings will be documented using a structured proforma. The correlation between ONSD, pupillary diameter, and GCS will be analyzed using appropriate statistical methods.

The study is expected to provide valuable insights into the use of POCUS-based ocular measurements as objective, bedside indicators of neurological function. If a significant correlation is found, these ultrasound parameters could assist emergency physicians in early triage, diagnosis, and management of patients with AMS—especially in settings where neuroimaging is delayed or unavailable. By integrating these non-invasive tools into routine emergency practice, the study hopes to improve patient care through faster and more reliable neurologic assessments.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age more than or equal to 18 years
  • Patients presenting with altered mental status.

排除标准

  • Severe ocular trauma, glaucoma, optic nerve abnormalities or conditions preventing accurate ultrasound.
  • History of significant ophthalmic pathology.
  • Inadequate ultrasound image quality.
  • Patients with pinpoint pupil on presentation.
  • Patients on topical ophthalmic drugs.

结局指标

主要结局

Correlation between pupillary diameter measured by ultrasound with Glasgow Coma Scale score in patients presenting with altered mental status in the emergency department.

时间窗: Within 6 hour of admission.

次要结局

  • 1.Correlation between optic nerve sheath diameter measured by ultrasound with Glasgow Coma Scale score in patients presenting with altered mental status in the emergency department.(2.Correlation between pupillary diameter and optic nerve sheath diameter measured by ultrasound with Glasgow Coma Scale scores in patients presenting with altered mental status in the emergency department.)

研究者

发起方
Akshay S Suresh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Akshay S Suresh

ABVIMS and Dr RML Hospital

研究点 (1)

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