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临床试验/CTRI/2025/08/093170
CTRI/2025/08/093170尚未招募4 期

Prospective Comparison Of Retromolar And Submental Intubation Techniques In Maxillofacial Trauma Surgery Patients In The Age 18 Years And Above—A Randomized Clinical Trial

Govt medical college and hospital Nagpur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Assess visibility, accessibility, and maneuverability of the Surgical Field: To assess how each intubation technique affects the visibility, accessibility and maneuverability of the surgical field using following criteria.

研究概览

简要总结

Effective airway management is crucial for patient safety during surgery The rationale for this study is to compare the outcomes of retromolar intubation and submental intubation in maxillofacial fracture patients for the purpose of identifying which technique offers superior results The study can contribute to evidencebased practices that enhance patient safety reduce the risk of airwayrelated complications and improve overall surgical success Although both retromolar and submental intubation techniques are used in practice there is extremely limited comprehensive research comparing them directly This study aims to fill that gap by providing a detailed comparison based on empirical data thus contributing to the body of knowledge and supporting the development of best practices in maxillofacial surgery

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adults (typically aged 18 years and above).
  • Diagnosed with panfacial/complex maxillofacial fractures requiring surgical repair.
  • Patients requiring management under general anesthesia.
  • Willingness and ability to provide informed consent.

排除标准

  • Pediatric patients (under 18 years of age).
  • Patients with severe comorbidities that may affect surgical outcomes or airway management decisions.
  • Patients undergoing emergency procedures where immediate intubation methods (such as traditional oral intubation) are preferred.
  • Patients who decline participation or are unable to provide informed consent.

结局指标

主要结局

Assess visibility, accessibility, and maneuverability of the Surgical Field: To assess how each intubation technique affects the visibility, accessibility and maneuverability of the surgical field using following criteria.

时间窗: at baseline

次要结局

  • Evaluate the Incidence of Complications: frequency and types of complications associated with each intubation technique, including tube bleeding, displacement, accidental extubation, infections, intraoperative tube injuries, kinking of the tube, need for third molar extraction, need for tube to be retained after surgery, salivary fistula, scarring and wound healing problems etc,(o Examine the Technical Difficulty: evaluate the technical challenges and ease of performing each intubation technique by assessing the skill required, the frequency of difficulties encountered, no. of attempts, need of assistance and the overall feasibility of each method)

研究者

发起方
Govt medical college and hospital Nagpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kainat Khan

Govt medical college and hospital, Nagpur

研究点 (1)

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