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临床试验/NCT01495273
NCT01495273撤回不适用

Adaptation of Nerve Stimulation Technology to Aid Transtracheal Needle Insertion and Injection

University of Alberta1 个研究点 分布在 1 个国家开始时间: 2017年5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
撤回
试验地点
1
主要终点
Needle tip placement in tracheal lumen

研究概览

简要总结

Various medical procedures require different objects to be inserted into the airway; for example, a bronchoscope - a fibreoptic camera device - can be guided down the windpipe to gain real-time images of the airway. Since inserting objects down the throat is uncomfortable for most patients, doctors have several options, one of which is putting the patient to sleep using general anesthetic before inserting something into the windpipe. This may not always be the best option, especially in cases where the patient needs to be awake during the procedure. In these cases, the doctor may 'freeze' the windpipe before inserting a scope or a tube into the airway. For this, the doctor inserts a needle through the front of the neck and injects local anesthetic. Inserting a needle into the windpipe comes with some risks to the patient, and the doctor wants to avoid puncturing nearby structures, such as arteries, veins, and the esophagus. The investigators have come up with a new method for accurately guiding a needle into the airway that will alert the user when they have successfully placed the needle tip in the windpipe. The investigators hypothesize that this new method will prove to be beneficial to clinicians and emergency medical personnel who need a fast, easy, and reliable way to insert a needle into the airway.

详细描述

Background and rationale

The trachea can be anesthetized by several different methods, one of which is transtracheal injection of a local anesthetic such as lidocaine. This technique is performed to prepare a patient for a variety of procedures, including awake fibreoptic intubation and cricothyroidotomy. Tracheal anesthesia is performed by first identifying the cricothyroid ligament; this structure is generally located by placing one finger on the thyroid cartilage and another on the cricoid cartilage. Approximately 4-6 mL of local anesthetic is delivered through a small needle or an intravenous catheter inserted in the neck midline. Anesthesia occurs quickly and permits the patient to be awake and aware during the procedures that follow.

Insertion of a needle into the trachea is not without risk to the patient. Several complicating factors affect the success rate of tracheal needle insertion, and in emergency situations where oxygen must be delivered through the insertion site, as in cricothyroidotomy, accurate needle insertion can mean the difference between life and death for the patient. One complicating factor in this procedure is that the thyroid cartilage and the cricoid cartilage can be difficult to identify, especially in obese people. Needle insertion is made more complicated due to the anatomy surrounding the cricothyroid membrane: the carotid artery and jugular vein lie laterally to the membrane, the cricothyroid artery is located superiorly and laterally, and the highly vascularized thyroid gland is located inferiorly. Intravascular injection of anesthetic can lead to a seizure, and inaccurate injection could lead to anesthesia of surrounding nerves. There is also a risk of puncturing through the posterior wall of the trachea, which may cause esophageal perforation.

Given these complications, a quick and easy method of ensuring accurate tracheal needle insertion, while avoiding damage to surrounding tissues, would greatly benefit clinicians and could potentially save lives in emergency situations. We wish to evaluate a simple technique to guide a needle tip into the trachea that mitigates the risks of conventional methods of needle insertion. We will use nerve stimulation equipment to aid in the guidance and placement of a needle tip into the tracheal lumen, which we predict will be faster and more accurate than current conventional methods. The nerve stimulation technology can alert the user to the exact moment the needle tip is suspended in the trachea and also alerts the user to when the needle tip is in contact with body tissue, avoiding accidental puncture of the lateral and posterior tracheal walls. We believe that this method of electrically-guided needle insertion will be a significant improvement over current methods of percutaneous needle insertion and transtracheal injection.

Study objective To assess the value of nerve stimulation equipment for guidance and placement of a needle-catheter assembly for transtracheal injection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •Adult (18 years of age or older) patients who have provided informed consent.
  • •Require awake fibreoptic intubation.

排除标准

  • •Inability to consent due to language barrier or incapacity to consent.
  • •Known upper airway pathologies
  • •Known oro-pharyngeal or laryngeal disease, including any swelling, tumour, or infection.
  • •Previous radiotherapy or operations on the neck.
  • •Cervical spine fractures.

研究组 & 干预措施

Nerve stimulator

Experimental

Experimental group; will undergo transtracheal injection with needle connected to nerve stimulator.

干预措施: Transtracheal injection (Procedure)

Standard needle/syringe

Active Comparator

Control group; will undergo transtracheal injection with standard needle/syringe assembly.

干预措施: Transtracheal injection (Procedure)

结局指标

主要结局

Needle tip placement in tracheal lumen

时间窗: From positioning of the patient to anesthesia of the trachea; approximately 10 minutes

After injection of local anesthetic into the skin of the neck, a needle connected to a syringe containing 4-6 mL 2-4% lidocaine will be inserted through the cricothyroid membrane into the tracheal lumen. Success will be recorded as accurate puncture of the cricothyroid membrane and trachea and injection of lidocaine into the tracheal lumen.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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