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临床试验/NCT05090852
NCT05090852已完成不适用

High Velocity Nasal Insufflation (Hi-VNI) Use in Upper Airway Surgery

Natasha Mirza2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Natasha Mirza
入组人数
31
试验地点
2
主要终点
Surgical Case Completion Rate Using HVNI With or Without Converting to Alternative Mode of Oxygenation

研究概览

简要总结

The goals of this study are to establish the efficacy of Hi-VNI (High Velocity Nasal Insufflation) in upper airway surgery from the anesthesiologist's and surgeon's perspectives, and to describe the ideal patient and the ideal pathology as well as suitable clinical scenarios when this oxygenation technique should be selected.

详细描述

The most challenging aspects of laryngeal and laryngotracheal procedures are difficulty of exposure and airway management. These procedures require use of microlaryngeal instruments through a small lumen of a rigid laryngoscope, and are oftentimes difficult to perform with a standard endotracheal tube in place. Similarly, when performing endoscopic evaluation of the trachea, access to the space and visualization of the entire 360-degree view of the trachea is crucial.

To overcome these challenges, a number of techniques for oxygen delivery have evolved over time. Among them are use of a small endotracheal tube, use of jet ventilation and intermittent apnea with periodic removal of the endotracheal tube. The aforementioned methods of airway management carry inherent risks of airway injury, can be accompanied by brief periods of hypoxia or hypercarbia, and can sometimes lead to tenuous airway management scenarios for both the surgeon and the anesthesiologist when clear communication and familiarity with the airway management plan during the procedure are sub-optimal. For this reason, there is an ongoing search for acceptable solutions to minimize these risks during upper airway surgery.

One of the newly emerging advanced oxygenation techniques, also known as Hi-VNI (High Velocity Nasal Insufflation), allows for delivery of humidified oxygen through a specialized high-flow nasal cannula at rates of up to 40 l/min. This non-invasive high flow respiratory support system is currently being used in the treatment of respiratory failure in both adult and pediatric patients. This technique provides sustained oxygenation due to reduction in airway resistance, a build-up of airway pressure with oxygen-rich gas and active gas exchange, which lead to flushing of anatomic dead space, and delivery of oxygen into the lungs. This oxygenation technique can be used both in spontaneously breathing patients and under apneic conditions, while providing an unobstructed surgical view with the glottis, subglottis and trachea fully accessible for instrumentation.

The goal of this study is to establish the efficacy of Hi-VNI in upper airway surgery, to document the advantages and disadvantages of this technique from the standpoint of the airway surgeon and the anesthesiologist, and to provide more information about the optimal patient and airway pathology as well as suitable clinical scenarios when Hi-VNI device can be used for oxygenation during upper airway surgery. The researchers hypothesize that in appropriate clinical situations, Hi-VNI can ease airway management, shorten case duration, and provide superior operating conditions including space for instrumentation during upper aerodigestive tract procedures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Scheduled to undergo elective upper airway surgery at the University of Pennsylvania

排除标准

  • Underlying medical conditions in which brief periods of hypoxemia or hypercarbia are not well tolerated
  • Coronary artery disease
  • Severe heart failure with EF < 40% or implanted ICD
  • Pulmonary hypertension or pulmonary fibrosis
  • History of increased intracranial pressure
  • History of skull base or intracranial surgery
  • Severe nasal obstruction
  • Extremely low or extremely high BMI (BMI <16 or >40)
  • At high risk for aspiration
  • Taken to OR for urgent or emergent upper airway surgery

结局指标

主要结局

Surgical Case Completion Rate Using HVNI With or Without Converting to Alternative Mode of Oxygenation

时间窗: 1 day

For each case, the ability to complete the surgical procedure with use of only Hi-VNI device for oxygenation will be assessed. Patients were oxygenated with Hi-VNI at a flow rate of 40 L/min and FiO2 of 100%. Patients with spO2 \< 93 or TcCO2 \> 65 during the procedure were converted to an alternative means of oxygenation, including mask ventilation and endotracheal intubation. The primary outcome measure is the surgical case completion rate with or without converting to alternate means of oxygenation.

次要结局

未报告次要终点

研究者

发起方
Natasha Mirza
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Natasha Mirza

Professor

University of Pennsylvania

研究点 (2)

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