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临床试验/NCT06270797
NCT06270797招募中不适用

Pre-anesthesia Imaging-based Respiratory Assessment and Analysis

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30,000
试验地点
1
主要终点
A pre-anesthesia evaluation

研究概览

简要总结

This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system.

详细描述

Anesthesia respiratory assessment is an important issue for anesthesiologists to evaluate the respiratory status and airway management of patients before surgery. The American Society of Anesthesiologists (ASA) updated its guidelines in 2022, emphasizing the importance of comprehensive respiratory assessment in the guidelines.

Various risk factors have been proposed in past literature for discussion, and corresponding to these risk factors, there is currently no single factor that can predict difficult intubation completely. Existing investigations into difficult intubation factors mostly focus on high-risk populations, including patients with morbid obesity, where significant differences have been identified but not developed into predictive models.

With the rapid development of AI-related technologies in recent years, numerous image-related AI frameworks have been proposed. In recent years, attempts have been made to combine various clinical risk factors using machine learning methods to create automated prediction models for difficult intubation. However, their effectiveness has not met expectations, reflecting the significant clinical problem of difficulty in prediction that remains unresolved.

This study is an observational study aimed at analyzing and establishing patient image data, refining various data engineering techniques, and optimizing existing prediction model frameworks to enhance their medical value. Additionally, the focus of this project will be on establishing more prediction models to improve existing clinical decision support systems.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing general anesthesia
  • Patients who can undergo pre-anesthetic consultation and airway examination.

排除标准

  • Patients unable to undergo pre-anesthetic consultation and airway examination.
  • Patients requiring emergency surgery.
  • Vulnerable populations.

结局指标

主要结局

A pre-anesthesia evaluation

时间窗: pre-anesthetic consultation about 20 min

The examination includes airway assessment and dental evaluation.

difficult intubation prediction

时间窗: after pre-anesthetic consultation about 5 min

The prediction of difficult intubation from pre-anesthesia evaluation and non-invasive imaging capture

Perform non-invasive imaging capture.

时间窗: pre-anesthetic consultation about 5 min

The capture involves non-invasive imaging of the patient's facial features through standard basic photography, excluding any additional radiographic imaging examinations.The patient's images will be stored in de-identified form.

次要结局

  • safely discharged from post-anesthesia care unit (postoperative recovery room)(2 hours)
  • time to successfully extubate the nasotracheal tube after anesthesia(from the end of surgery to the post-anesthesia care, assessed up to one hour)
  • side effects and adverse events(intraoperative and postoperative stages, assessed up to 48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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