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临床试验/NCT06236971
NCT06236971已完成不适用

Effect of Lateral Positions on the Shape of Upper Airway Under Sedation

First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年2月5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
31
试验地点
1
主要终点
minimum cross-sectional area (MCSA)

研究概览

简要总结

The severity and frequency of respiratory events is increased in the supine body posture compared with the lateral position in emergency, difficult airway patients. The mechanism responsible is not clear but may relate to the effect of position on upper airway shape and size. 3D finite element model of upper airway filling based on MRI image reconstruction can effectively reflect the anatomy of the upper airway. This study compared the effect of body position on upper airway shape and size in individuals with lateral position among sedated subjects.

详细描述

Anesthesiologists may encounter situations in which a accidental loss of airway patency occurs in patients in a lateral patient position during surgery. Intubation is required in the lateral position in cases of oropharyngeal bleeding to reduce the risk of aspiration, or in airway management in some patients with limited posture. The severity and frequency of respiratory events is increased in the supine body posture compared with the lateral position in emergency, difficult airway patients. The mechanism responsible is not clear but may relate to the effect of position on upper airway shape and size secondary to gravitational effects. Lateral positioning decreases upper airway obstruction in sleeping individuals, children breathing spontaneously, and adults during general anesthesia. The mechanical upper airway properties may become the dominant factor governing upper airway collapsibility during sedation due to the significant depression of consciousness and the impairment of neural mechanisms controlling compensatory neuromuscular responses. Anesthesiologists and surgeons who are responsible for airway management during procedures under sedation and the perioperative period should be well versed with the physiological and pathophysiological mechanisms affecting upper airway patency. 3D finite element model of upper airway filling based on MRI image reconstruction can effectively reflect the anatomy of the upper airway.

The primary aim of this study was to determine the changes in upper airway shape and size that occur when sedated, spontaneously breathing adults are placed in the lateral position. These findings may provide new guidance for the evaluation and prediction of difficult airway during clinical anesthesia.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged over than 18 years and less than 100 years
  • The American Society of Anesthesiologists (ASA) score was grade I to II
  • There was no serious cardiopulmonary disease

排除标准

  • Unable to maintain oxygenation before or during the examination and requiring intervention
  • Those with preoperative arrhythmia requiring intervention
  • Thosewith severe hematological diseases, severe metabolic diseases, severe liver and kidney organ insufficiency
  • Those do not consent to participate in the study

结局指标

主要结局

minimum cross-sectional area (MCSA)

时间窗: through study completion, an average of 2 months

minimum cross-sectional area (MCSA) of upper airway-related sagittal, cross-sectional, and coronal planes

lateral diameters

时间窗: through study completion, an average of 2 months

lateral diameters

minimum anteroposterior

时间窗: through study completion, an average of 2 months

minimum anteroposterior diameters

pharyngeal volume

时间窗: through study completion, an average of 2 months

pharyngeal volume

次要结局

  • Change of heart rates (HR) in beats per minute(before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position)
  • three-dimensional geometrical modeling of the upper airway(through study completion, an average of 2 months)
  • Change of oxygenation (SpO2, %)(before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position)
  • Change of respiratory rates (RR) in respirations per minute(before examination, immediately after examination at supine position, immediately before examination at lateral position, immediately after examination at lateral position)

研究者

发起方
First Affiliated Hospital of Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

xiangming fang

Director, Head of Anesthesiology and Critical Care, Principal Investigator, Professor

First Affiliated Hospital of Zhejiang University

研究点 (1)

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