跳至主要内容
临床试验/NCT06839261
NCT06839261已完成不适用

Efficacy and Reliability of Photo-Based Artificial Intelligence Algorithms in Assessing Difficulty of Intubation With a Double-Lumen Tube

Ankara Ataturk Sanatorium Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
260
试验地点
1
主要终点
Intubation Difficulty Scale (IDS)

研究概览

简要总结

The complexity and difficulty of intubation with double lumen tubes requires the use of advanced technologies in the management of this procedure. The potential of photo-based artificial intelligence algorithms to predict and minimize the difficulties encountered during intubation is the main motivation for this study.

The utilization of artificial intelligence algorithms within the domain of airway management holds considerable promise in providing real-time feedback to anesthesiologists, enhancing the efficacy of intubation procedures, and reducing the occurrence of complications. Specifically, photo-based AI systems can facilitate a more comprehensive understanding of airway anatomy by analyzing images captured prior to and during intubation, thereby enhancing the management of complex cases.The objective of this study is to examine the efficacy and reliability of photo-based artificial intelligence algorithms in evaluating the complexity of intubation with a double lumen tube.The integration of artificial intelligence into the intubation process is intended to enhance patient outcomes and establish a new benchmark for anesthesia practice. This study aims to address the existing gap in the literature and provide innovative approaches to clinical practice.

Informed consent was obtained from patients undergoing thoracic surgery operations, and demographic data (age, height, body weight, body mass index, gender), American Society of Anesthesiologists (ASA) score, type of operation, and comorbid diseases (diabetes mellitus, hypertension, coronary artery disease, chronic kidney disease, chronic obstructive pulmonary disease, asthma, obstructive sleep apnea) were obtained. Thoracic and/or extrath oracic malignancy history), parameters considered as risk factors for difficult intubation (history of previous difficult intubation, LEMON criteria (look externally, evaluate, mallampathy, obstruction, neck mobility), upper lip bite test) and photographs of the patients (including head and neck region) will be recorded in six different directions and ways with a professional camera (actively used in our hospital) in the preoperative period. During the intraoperative phase, the Cormack-Lehane scoring system will be employed, and the intubation process with a double-lumen tube will be evaluated for ease or difficulty. Intraoperative complications related to the operation will also be documented.The data will then be processed using Python 3 programming language and open-source libraries to calculate artificial intelligence algorithms. In the event of incomplete patient data, data imputation techniques will be employed to supplement the artificial intelligence program.

The primary outcome variable of the study is the rate at which the photo-based artificial intelligence algorithm predicts whether intubation with a double lumen tube is easy or difficult.The secondary outcome variable is the comparison of the rate of prediction of intubation with double lumen tube by photo-based artificial intelligence algorithms and the rate of prediction of intubation with double lumen tube by conventional methods.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Undergoing thoracic surgery
  • •Giving informed consent
  • •Over 18 years of age
  • •Double lumen tube used for intubation
  • •ASA (American Society of Anesthesiologist)1-2-3

排除标准

  • •Emergency surgeries
  • •ASA 4 and above
  • •Head and neck tumor, history of surgery/RT related to tumor
  • •Presence of syndrome that will cause difficult intubation

结局指标

主要结局

Intubation Difficulty Scale (IDS)

时间窗: During the operation

The Intubation Difficulty Scale (IDS) is an objective way to classify easy and difficult intubation. A score ≤ 5 indicates an easy or mildly difficult intubation, while IDS \> 5 suggests difficult intubation, requiring additional techniques or attempts.

次要结局

未报告次要终点

研究者

发起方
Ankara Ataturk Sanatorium Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Onur Kucuk

Principal Investigator

Ankara Ataturk Sanatorium Training and Research Hospital

研究点 (1)

Loading locations...

相似试验