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临床试验/NCT03640442
NCT03640442已完成不适用

Modified Ramped Position for Intubation of Obese Females: a Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Incidence of difficult laryngoscopy

研究概览

简要总结

The aim of this work is to investigate the feasibility of using the modified a ramped position for intubation of obese females in comparison to the traditional ramped position.

详细描述

Adequate conditions for endotracheal intubation require appropriate positioning of head and neck. The sniffing position had been described as the most appropriate head position for endotracheal intubation. Sniffing position is achieved through two main components: flexion of the neck by 35° (achieved by head elevation) and extension of the head by 15° 2 to have the sternum at the same level of external auditory meatus 34. Sniffing position has the advantage of alignment of the three axes: oral, pharyngeal, and laryngeal axes for reaching the optimal laryngeal visualization.

In obese patients, it is recommended to put the patient in the ramped position (back-up position with the tragus of the ear is at the level of the suprasternal notch) in addition to the sniffing head-and-neck position. Some commercially available pillows were introduced to facilitate laryngoscopy in obese patients such as: Troop elevation pillow and Rapid airway management positioner.

In addition to difficult laryngeal visualization, another problem commonly confronts anesthetists during intubation of obese females; that is impedance of laryngoscopy by large breasts. This problem commonly hinders the intubation process and might lead to serious hypoxia. Most of the positions described in literature were concerned with facilitating laryngeal visualization. No position to the best of our knowledge was applied to aid the introduction of the laryngoscope in the presence of large breasts.

The investigators hypothesized that using a special pillow to achieve a modified ramped position (by slight extension of the neck) at the beginning of the laryngoscopy would bring the breasts away from the laryngoscope. After successful introduction of the laryngoscope in the oral cavity, the head will be elevated using a head rest to achieve ordinary ramped position if laryngeal visualization was not adequate.

The aim of this work is to investigate the feasibility of using the aforementioned modified ramped position for intubation of obese females in comparison to the traditional ramped position.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female patients
  • obese (with body mass index above 30 kg per squared meter)
  • Scheduled for surgery under general anesthesia.

排除标准

  • Patients with scars in the face or neck.
  • Edentulous patients.
  • Patients with airway masses.

结局指标

主要结局

Incidence of difficult laryngoscopy

时间窗: 5 minutes after induction of general anesthesia

defined as "failure to insert the laryngoscope in the oral cavity due to large breast with the need to reposition the patient to insert the laryngoscope"

次要结局

  • Time till complete visualization of the vocal cords(5 minutes after induction of general anesthesia)
  • Oxygen saturation(5 minutes after induction of general anesthesia)
  • End-tidal carbon dioxide(5 minutes after induction of general anesthesia)
  • Heart rate(5 minutes after induction of general anesthesia)
  • Time of laryngoscopy(5 minutes after induction of general anesthesia)
  • incidence of difficult mask ventilation(5 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Hasanin

Assistant professor

Cairo University

研究点 (1)

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