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临床试验/CTRI/2024/11/077012
CTRI/2024/11/077012已完成不适用

Predictors of Difficult Laryngoscopy on Computed Tomography in Patients with Faciomaxillary Injury - A Prospective, Observational Study

Raavi Rishitha1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年12月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
To determine CT guided predictors of difficult laryngoscopy in faciomaxillary trauma patients.

研究概览

简要总结

Airway management of patients with maxillofacial trauma poses serious challenges due to disarranged anatomy as well as associated injuries, haemorrhage, and edema, with almost 24-30% incidence of difficult laryngoscopy and/or intubation. Therefore, accurately predicting challenging laryngoscopy is vital to reduce adverse outcomes and improve patient safety.

Traditional airway assessment methods—such as measuring inter-incisor and thyromental distances, using the modified Mallampati Score, evaluating neck mobility, and performing the upper lip bite test—are often unreliable, demonstrating poor predictive power, sensitivity, and specificity. These bedside evaluations may be impractical in patients with facial maxillary injuries (FMI) due to their altered external anatomy, swelling, blood or secretions, extreme pain, and sometimes cervical spine injuries.

As a result, there is an urgent need for objective predictors of difficult laryngoscopy. Previous studies have shown that radiological assessments, particularly sonography and CT imaging, are invaluable for airway evaluation. However, ultrasound can be challenging and uncomfortable for patients due to local edema. We propose that CT-guided parameters, including both airway characteristics and fracture types, can reliably predict difficult laryngoscopy in individuals with faciomaxillary trauma. Hence we have planned this study with the aim of determining radiological (CT imaging) predictors, including both airway parameters as well as type of fractures, of difficult laryngoscopy in patients with faciomaxillary injury.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologists (ASA) physical status I-II patients, in the age group of 18-65 years, with Lefort type I/II/III Fracture / Bilateral mandibular / parasymphysis menti fracture / Displaced coronoid / condyloid fracture scheduled to undergo maxillofacial injury fixation under general anaesthesia will be enrolled in the study.

排除标准

  • Isolated zygoma fractures
  • Isolated nasal bone fractures
  • History of surgery/burns/radiotherapy of the head and neck region
  • Tracheostomised patients
  • Refusal to give consent for the study.

结局指标

主要结局

To determine CT guided predictors of difficult laryngoscopy in faciomaxillary trauma patients.

时间窗: At baseline (time of endotracheal intubation)

次要结局

  • To determine the best model fit predictors of difficult laryngoscopy using stepwise logistic regression.
  • Incidence of difficult laryngoscopy in faciomaxillary trauma patients.(At baseline (at the time of endotracheal intubation))
  • First pass intubation success rate(At baseline (at the time of endotracheal intubation))

研究者

发起方
Raavi Rishitha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Raavi Rishitha

PGIMER

研究点 (1)

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