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临床试验/NCT06939998
NCT06939998尚未招募不适用

A Nontraditional Approach for Awake Fiberoptic Nasotracheal Intubation. A Randomized Controlled Superiority Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年5月15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
入组人数
112
试验地点
1
主要终点
Time taken for intubation.

研究概览

简要总结

The goal of this clinical trial is to learn if awake nasotracheal fiberoptic intubation through an endotracheal tube inserted in the nasopharynx would be quick and have fewer complications than the conventional technique. The main questions it aims to answer are:

which technique of intubation is faster, with more patient comfort and satisfaction? which technique has fewer complications like cough, bleeding, and laryngospasm? Researchers will compare intubation with the conventional fiberoptic technique for intubation to awake nasotracheal fiberoptic intubation through an endotracheal tube inserted in the nasopharynx.

Participants will be monitored throughout the procedure for:

  1. The duration of the intubation procedure
  2. The mean peripheral oxygen saturation
  3. Hemodynamic variables (HR, MAP)

详细描述

A nontraditional approach for awake fiberoptic nasotracheal intubation. A randomized controlled superiority trial Introduction It takes skill and specialized equipment to intubate someone with an anticipated difficult airway. The American Society of Anaesthesiologists and other European authors advise awake fiberoptic intubation (FOB). An awake patient can protect the airway. When a patient breathes independently until the airway is secured, awake fiberoptic intubation increases safety. In addition to requiring awake flexible fiberoptic intubation, difficult airway instances such as limited jaw mobility, restricted mouth opening, surgical interventions, or procedures planned in the oral cavity also require the nasotracheal route for intubation. Compared to oral intubation, nasal intubation is typically more straightforward and more successful.

Negotiating the endotracheal tube can be challenging since initial resistance is experienced during the passage of the bronchoscope and endotracheal tube (ET). However, the nasal approach gives an aligned airway to the larynx and trachea and holds the tube more stably. Gentle force is needed to overcome this resistance, which could cause the nose passage's friable mucosa to bleed. Coughing during a flexible fiberoptic bronchoscopy can make it difficult to see the vocal cord because bleeding in the nasopharynx and oropharynx can irritate the airway and cause coughing.

Berman and Ovassapian airways are available to help with awake flexible fiberoptic intubation via oral route. These airways provide a passageway for the ET tube and bronchoscope. However, the nasal approach does not have access to such an airway. A fiberoptic bronchoscope is usually passed through the more patent nostril to reach the nasopharynx. It then follows the main nasal pathway at the nose floor along the superior aspect of the hard palate and the lateral aspect of the nasal septum inferior to the lower turbinate. Once there, the operator can identify the pharyngeal structures, such as the base of the tongue and the epiglottis, which are primarily "in-fall" and prevent clear views of the larynx, necessitating a jaw thrust to visualize the laryngeal structures for patients who are scheduled to be intubated under general anesthesia so a wake fiberoptic is preferred in anticipating difficult airway.

An endotracheal tube (ET) can be inserted along the FOB cable that has already advanced into the trachea, making FOB nasal intubation easier and faster. This is achieved by inserting a modified split tube nasally down to or near the larynx, which allows the FOB cable to be immediately in front of the larynx without the need to confirm the anatomical details of the nasopharyngeal-laryngeal journey required during classic nasal FOB intubation.

This study hypothesized that awake nasotracheal fiberoptic intubation through an endotracheal tube inserted in the nasopharynx would be quick and have fewer complications than the conventional technique. This study compares the time to intubation and safety of FOB nasal intubation as classically done and thorough endotracheal tube.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age between 20 and 60 years,
  • •ASA (American Society of Anesthesiologists) grade I to IV, and an
  • •indication of awake fiberoptic nasal intubation.

排除标准

  • •Patients who refuse to undergo the procedure and
  • •patients with any absolute contraindication for nasal intubation like head trauma, suspected base of skull fractures, nasal mass, or deviated nasal septum

研究组 & 干预措施

CFOBI conventional fiberoptic intubation

Experimental

a 5.0-mm flexible fiberoptic bronchoscope (Pentax) will be loaded with an endotracheal tube of the proper size (7.5 for male and 7.0 for female patients). The bronchoscope tip will then be introduced into the nasal cavity, and the vocal cords will be detected.

干预措施: CFOBI (Procedure)

FOBIET nasotracheal fiberoptic intubation through an endotracheal tube in the nasopharynx

Active Comparator

FOBIET: an endotracheal tube (ET) is initially inserted into the nasal cavity, and then a flexible fiberoptic bronchoscope is introduced through it. The endotracheal tube will be connected to a catheter mount by which the investigator can deliver oxygenation. When using a nasal endotracheal tube, the tip is lubricated with 2% lignocaine jelly before being inserted into the nasal cavity and pushed up and down to allow the jelly to spread. The fiberoptic bronchoscope descends through the endotracheal tube after being inserted into the nasal passage as a nasal airway in the direction of the vocal cords until they can be seen

干预措施: FOBIET (Procedure)

结局指标

主要结局

Time taken for intubation.

时间窗: up to 7 month

The duration of the intubation procedure will be recorded in minutes, starting from the point at which the scope is inserted into the nares and ending with the ET cuff being inflated.

次要结局

  • Number of desaturation episodes(up to 7 month)
  • Occurrence of airway obstruction.(up to 7 month)
  • Patient comfort(up to 7 month)
  • Occurrence of other adverse effects(up to 7 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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