跳至主要内容
临床试验/NCT07846748
NCT07846748尚未招募不适用

Correlation Between Bedside Anatomical Indicators and Lifting Force and Glottic Exposure Under Different Video Laryngoscopy Techniques

Second Hospital of Shanxi Medical University0 个研究点目标入组 200 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
主要终点
Peak Lifting Force with Direct Epiglottis Elevation

研究概览

简要总结

This single-center prospective observational study plans to enroll 196 patients undergoing elective general anesthesia. The study aims to investigate the correlation between preoperative bedside anatomical indicators (including modified Mallampati classification, upper lip bite test, mouth opening, head circumference, and thyromental distance) and the peak lifting force applied during video laryngoscopy, as well as the degree of glottic exposure (POGO score). The study will also evaluate the potential benefit of the direct epiglottis elevation technique in specific anatomical subgroups. After anesthesia induction, the same anesthesiologist will perform video laryngoscopy using two distinct techniques in a fixed sequence: the indirect (vallecula) method and the direct (subepiglottic) method. Peak lifting force will be quantitatively measured in real-time using a resistive thin-film pressure sensor attached to the laryngoscope blade. The primary outcomes are the POGO scores and peak lifting forces under both techniques. The secondary outcome includes the change in POGO score (ΔPOGO) between techniques. The study will provide quantitative evidence regarding the "anatomy-force-view" relationship and aid in individualized clinical decision-making for video laryngoscopy intubation.

详细描述

This study is a single-center, prospective, observational study. A total of 196 adult patients scheduled for elective surgery under general anesthesia requiring orotracheal intubation will be enrolled. Preoperative bedside anatomical assessment will be performed by a standardized, blinded evaluator. The assessed indicators include mouth opening, thyromental distance, modified Mallampati classification, upper lip bite test, head circumference, and neck circumference. After standard anesthesia induction, video laryngoscopy will be performed by an experienced anesthesiologist. Two techniques will be evaluated in a fixed sequence: (1) Indirect epiglottis elevation (vallecula method): the blade tip is placed in the vallecula to indirectly elevate the epiglottis by lifting the tongue base. (2) Direct epiglottis elevation (subepiglottic method): the blade tip is advanced past the vallecula and placed directly under the laryngeal surface of the epiglottis to actively lift it. A resistive thin-film pressure sensor attached to the video laryngoscope blade will continuously record real-time force data, and the peak lifting force will be extracted for analysis. Glottic exposure will be evaluated using the Percentage of Glottic Opening (POGO) score. Between the two assessments, mask ventilation will be performed for at least 2 minutes to maintain SpO2 ≥ 98%. All procedures and data collection will adhere to the approved protocol by the Ethics Committee of the Second Hospital of Shanxi Medical University (Approval No. [2026] YX No. 172). Statistical analyses will be performed using SPSS 26.0 and R software, including Spearman rank correlation, Kruskal-Wallis test, and multiple linear regression with Bootstrap validation.

研究设计

研究类型
观察性
观察模型
队列研究
时间视角
前瞻性

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • - Age 18 to 75 years
  • ASA physical status I to III
  • Scheduled for orotracheal intubation under video laryngoscopy guidance
  • Written informed consent obtained

排除标准

  • Known history of difficult airway or anticipated need for awake intubation
    • Facial or neck trauma, burns, or surgical history affecting palpation of anatomical landmarks
    • Temporomandibular joint ankylosis or mouth opening < 2.0 cm
    • Edentulous patients

研究组 & 干预措施

Patients Undergoing Video Laryngoscopy

Adult patients scheduled for elective general anesthesia requiring orotracheal intubation under video laryngoscopy guidance. All participants will undergo both indirect and direct epiglottis elevation techniques in a fixed sequence.

干预措施: Direct Epiglottis Elevation (Subepiglottic Method) (Procedure)

结局指标

主要结局

Peak Lifting Force with Direct Epiglottis Elevation

时间窗: Perioperative

Peak lifting force (gf) measured by a resistive thin-film pressure sensor attached to the video laryngoscope blade during the direct (subepiglottic) technique.

Peak Lifting Force with Indirect Epiglottis Elevation

时间窗: Perioperative

Peak lifting force (gf) measured by a resistive thin-film pressure sensor attached to the video laryngoscope blade during the indirect (vallecula) technique.

POGO Score with Indirect Epiglottis Elevation

时间窗: Perioperative

Percentage of Glottic Opening (POGO) score assessed via video laryngoscopy using the indirect (vallecula) technique. The scale ranges from 0% to 100%, where higher scores indicate better visualization of the glottis (better outcome).

POGO Score with Direct Epiglottis Elevation

时间窗: Perioperative

Percentage of Glottic Opening (POGO) score assessed via video laryngoscopy using the direct (subepiglottic) technique. The scale ranges from 0% to 100%, where higher scores indicate better visualization of the glottis (better outcome).

次要结局

  • Delta POGO (ΔPOGO)(Perioperative)
  • Incidence of Difficult Glottic Exposure(Perioperative)

研究者

发起方
Second Hospital of Shanxi Medical University
申办方类型
其他
责任方
主要研究者
主要研究者

Zheng Guo

professor

Second Hospital of Shanxi Medical University

标识符

NCT 编号
NCT07846748
其他研究编号
[2026]YX172

日期

首次提交
(14天前)
首次发布
(昨天)
主要完成日期
(6个月后)
研究完成日期
(8个月后)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

相似试验