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临床试验/NCT07077317
NCT07077317已完成不适用

Examining the Effects of the Stop-Bang Scoring Model, Anthropometric Measurements, and Head Dimensions on Difficult Airway Prediction

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 1,044 人开始时间: 2025年8月13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
1,044
试验地点
1
主要终点
Incidence of Difficult Mask Ventilation

研究概览

简要总结

Airway-related complications are among the leading causes of anesthesia-associated morbidity and mortality. Therefore, the ability to predict difficult mask ventilation, laryngoscopy, and intubation before induction is essential to ensure proper preparation in patients at risk and avoid unnecessary airway manipulations in low-risk individuals. While numerous studies have focused on predicting difficult intubation, most have limited sample sizes and do not consider postoperative critical respiratory events.

In this prospective observational clinical study, we aim to investigate the relationship between commonly used preoperative airway assessment tools-including anthropometric measurements, Mallampati score, and the STOP-Bang questionnaire for obstructive sleep apnea-and the incidence of difficult mask ventilation, difficult laryngoscopy (Cormack-Lehane grading), difficult intubation, and critical respiratory events in the postoperative period.

The study will include adult patients (≥18 years) classified as ASA I-IV undergoing surgery under general anesthesia with endotracheal intubation. Data will be collected preoperatively, intraoperatively, and in the post-anesthesia care unit (PACU) by experienced anesthesia personnel. Postoperative critical respiratory events are defined as unexpected hypoxemia, hypoventilation, reintubation, or interventions required for upper/lower airway obstruction.

详细描述

Difficult airway management remains one of the most significant challenges in clinical anesthesia, often leading to severe complications such as hypoxemia, aspiration, and even cardiac arrest. Despite various clinical predictors, no single assessment method reliably identifies all patients at risk. This prospective, observational study aims to comprehensively evaluate the association between preoperative airway assessment parameters and both intraoperative airway difficulty and postoperative critical respiratory events.

The preoperative assessment will include demographic characteristics, comorbidities, ASA classification, Mallampati score, and detailed anthropometric airway measurements (neck circumference, thyromental distance, sternomental distance, interincisor gap, head dimensions, presence of beard/dentition, and neck mobility). Additionally, the STOP-Bang questionnaire will be administered to assess the risk of obstructive sleep apnea (OSA).

During induction and airway management, mask ventilation difficulty will be graded, Cormack-Lehane score during laryngoscopy will be recorded, and intubation will be evaluated in terms of the number of attempts and need for adjunctive devices (stylet, bougie, fiberoptic bronchoscope, videolaryngoscope, etc.).

In the postoperative phase, patients will be monitored for critical respiratory events including unexpected hypoxemia (SpO₂ <90%), hypoventilation (RR <8/min or PaCO₂ >50 mmHg), reintubation, and any interventions (e.g., airway support, bronchodilators, cold mist, etc.) required for upper or lower airway obstruction.

The outcomes of this study may help refine preoperative screening protocols and contribute to the development of risk-based airway management strategies aimed at improving patient safety.

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

  • •Age ≥ 18 years,
  • •ASA Physical Status I, II, III or IV,
  • •Undergoing elective surgery under general anesthesia with endotracheal intubation,
  • •Written informed consent provided

排除标准

  • •History of head and neck surgery or trauma causing anatomical deformity,
  • •Known congenital or acquired airway abnormality,
  • •Cervical spine surgery or instability,
  • •Age < 18 years

结局指标

主要结局

Incidence of Difficult Mask Ventilation

时间窗: Intraoperative (during anesthesia induction)

Evaluation of mask ventilation using a standard difficulty grading scale. 1. Mask Ventilation Successful 2. Mask Ventilation Requires Oral Airway 3. Mask Ventilation Requires Oral Airway And Assistant (Two Hands) 4. Mask Ventilation Failure

Incidence of Difficult Laryngoscopy

时间窗: Intraoperative (during laryngoscopy)

Cormack-Lehane grade III-IV views considered difficult laryngoscopy.

Incidence of Difficult Intubation

时间窗: Intraoperative (during intubation)

Defined as more than two attempts, or the requirement of adjuncts such as bougie, videolaryngoscope, or fiberoptic bronchoscope.

Occurrence of Postoperative Critical Respiratory Events

时间窗: Within the first 2 hours postoperatively (in PACU)

Events include unexpected hypoxemia (SpO₂ \< 90%), hypoventilation (RR \< 8/min or PaCO₂ \> 50 mmHg), reintubation, and active interventions for airway obstruction.

次要结局

  • Correlation Between STOP-Bang Score and Difficult Airway Incidence(Preoperative through intraoperative period)
  • Correlation Between Anthropometric Measurements and Critical Respiratory Events(Preoperative to postoperative period)
  • Correlation Between Anthropometric Measurements and Difficult Airway Management(Preoperative to intraoperative (induction period of anesthesia))

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Suleyman Camgoz

Asistant Professor

Kutahya Health Sciences University

研究点 (1)

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