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临床试验/NCT06637319
NCT06637319已完成不适用

Prevalence of Major Vessels Underlying the Potential Incision Site for Emergency Front of Neck Airway Access in Adult Surgical Patients With Impalpable Neck Anatomy

Mount Sinai Hospital, Canada1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Prevalence of blood vessels

研究概览

简要总结

Patients undergoing general anesthesia require assistance with their breathing and with the delivery of oxygen to their lungs. To achieve this, an anesthesiologist inserts a type of plastic breathing tube into the airway via the mouth called an endotracheal tube or laryngeal mask airway. In rare circumstances, the anesthesiologist may not be able to adequately provide oxygen via these methods. In this life-threatening situation, an anesthesiologist may be forced to make an incision in the front of the neck to access the trachea (windpipe) so that emergency oxygen can be provided. This life-saving technique is known as emergency front-of-neck access (eFONA) and is used to prevent low oxygen levels which cause irreversible brain damage and/or death.

This rarely performed procedure carries a risk of harm from bleeding, injury to the airway or inability to access the trachea to provide oxygen. Emergency front of neck access is more likely to be required in patients with abnormal airway anatomy, for example, in patients with obesity and large neck circumference, neck cancer, or a history of head and neck radiation therapy. Though the optimal technique for eFONA is not clear, prominent guidelines advise the use of an 8-10cm incision upwards from the top of the breastbone in order to identify airway structures which cannot be easily felt by the anesthesiologist from the front of the intact neck. This differs from patients who have airway structures which may be easily located at the front of the neck, whereby a smaller incision may be made or a needle inserted into the trachea (widepipe) to provide oxygen. The neck contains major blood vessels which lie close to the airway and these blood vessels may be injured during the 8-10cm incision, creating further difficulty accessing the airway to provide life-saving oxygen.

This study aims to assess for the presence and size of major blood vessels which may be damaged by this incision by using non-invasive ultrasound which will be placed on the skin of your neck to assess for such blood vessels prior to you undergoing anesthesia.

Our study aims to assess the normal anatomy in the adult population such as yourself to understand what to expect when managing patients who require this life-saving therapy.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy volunteers
  • •Ability to understand the rationale of the study assessments and to provide signed consent
  • •Ability to safely and comfortably take part in the study protocol

排除标准

  • •Participant refusal
  • •Participant less than 18 years old or older than 80 years old
  • •Participants who do not speak English or cannot give informed written consent without assistance

研究组 & 干预措施

Healthy Volunteers

Healthy volunteers > 18 years of age

干预措施: Ultrasound (Device)

结局指标

主要结局

Prevalence of blood vessels

时间窗: During the procedure (30 minutes

The prevalence of blood vessels at front of neck on ultrasound where an emergency front of neck access vertical incision would take place. In total five regions looked at: sternal notch, thyroid gland, cricoid cartilage, cricothyroid membrane and thyroid cartilage

次要结局

  • Depth of blood vessels(During the procedure (10 minutes))
  • Diameter of blood vessels(During the procedure (10 minutes))
  • Distance from midline(During procedure (10 minutes))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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