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临床试验/NCT07650604
NCT07650604尚未招募不适用

INTERPRETATION AND EVULATION OF THE PROXIMITY TO CLINICAL EXPERIENCE OF BISPECTRAL INDEX (BIS) IN PATIENTS UNDERGOİNG VERTEBRAL SURGERY USING ARTIFICIAL INTELLIGENCE PROGRAMS: A METHODOLOGICAL STUDY

Antalya Health Sciences University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2026年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
63
试验地点
1
主要终点
Clinical Experience

研究概览

简要总结

This study aims to interpret the Bispectral Index (BIS) monitoring method, which we routinely use for monitoring in scoliosis surgery, with artificial intelligence (AI) tools and to determine the accuracy and reliability of AI tools in clinical practice by comparing this interpretation with the interpretations of two clinicians experienced in BIS.

详细描述

The Bispectral Index (BIS) is an FDA-approved method for monitoring the depth of anesthesia. BIS combines time-domain, frequency-domain, and bispectral analysis of electroencephalography and is displayed as a dimensionless number between 0 (deep anesthesia) and 100 (awake); a value between 40 and 60 is suitable for surgical anesthesia. BIS shows good correlation with hypnotic state and anesthetic drug concentration, and its use can shorten recovery times. Recently, the use of artificial intelligence (AI) tools (Gemini 3.1, ChatCPT 5.5, Copilot 365 Premium) has become widespread in all fields. However, in the medical literature, there are only a limited number of recent studies that aim to enable emergency intervention in patients, increase clinical use, and obtain advice even if treatment recommendations are not available. Therefore, this study aims to interpret the BIS monitoring method, which we routinely use for monitoring in scoliosis surgery, with AI tools and to determine the accuracy and reliability of AI tools in clinical practice by comparing this interpretation with the interpretations of two clinicians experienced in BIS.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective vertebra surgery
  • aged 18-65
  • ASA score I-III
  • BMI <30 kg/m2

排除标准

  • patient's refusal
  • BMI >30 kg/m2
  • serious liver or kidney disease
  • ASA 4 ve more
  • anatomical abnormality at probe site
  • history of mental or neurological disease,
  • history of previous intracranial aneurysm or intracranial tumor surgery
  • history of moderate or severe pulmonary disease,
  • emergency surgery

结局指标

主要结局

Clinical Experience

时间窗: 12 hours

The proximity of AI programs to the clinical experience. The study will examine the percentage of times AI programs' interpretations and intervention recommendations regarding information processing stimulus (ISIS) are identical to those of two clinical practitioners.

次要结局

未报告次要终点

研究者

发起方
Antalya Health Sciences University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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