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临床试验/NCT03973294
NCT03973294已完成不适用

Assessment of Regional Lung Ventilation Distribution During Supraglottic and Subglottic Jet Ventilation by Electrical Impedance Tomography (EIT).

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月7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
30
试验地点
1
主要终点
Center of ventilation (COV)

研究概览

简要总结

Objective: To estimate regional lung volume changes by electrical impedance tomography (EIT) during supra- and subglottic jet ventilation via the jet laryngoscope and LaserJet catheter for performing laryngotracheal surgery.

Design: A monocentric, prospective, randomized study. Patients: Patients who require elective micro laryngo-tracheal surgery under jet ventilation.

Interventions: Patients undergoing elective micro laryngeal surgery will be assigned to subglottic JV via the new LaserJet catheter and supraglottic JV via the jet laryngoscope vice versa. The sequence of JV modes will be randomized (subglottic followed by supraglottic or supraglottic followed by subglottic JV). Hemodynamic and ventilation parameters will be monitored. Arterial blood gas samples will be drawn and the regional ventilation distribution assessed, using the EIT.

Outcomes measures: Reported EIT data of regional ventilation distribution, values of oxygenation and carbon dioxide elimination during the application of supra- and subglottic JV via jet laryngoscope and LaserJet catheter in patients undergoing laryngo-tracheal surgery. The purpose of this study is to investigate the influence of supraglottic and subglottic JV compared to standardized, controlled mask ventilation on measurements of pulmonary regional ventilation distribution by EIT, blood gas analyses and serological biomarkers.

详细描述

Surgical procedures of the larynx and trachea present special challenges for surgeons and anesthesiologists. To enable an unrestricted view of the operating field, ventilation of the patient is not performed over an endotracheal tube but instead over a steel laryngoscope or a thin catheter with Jet ventilation (JV). This enables precision surgical work, good visibility of the operating area and the safe use of various laser types. Over the last decades, different modalities of JV for laryngo-tracheal surgery have been developed. The former techniques of the supraglottic approach were improved with simultaneously applied low-frequency jet ventilation additionally to the high-frequency jet ventilation, called superimposed high-frequency jet ventilation (SHFJV). The SHFJV was developed in 1990 and was applied in several clinical trials [1-4] In recent years, a number of new catheters have been developed for the trans laryngeal subglottic approach of JV, like the translaryngeal Hunsaker MonJet Ventilation catheter and its successor, the LaserJet catheter. These catheters though can be used only with the HFJV. They provide less vocal cord movement and precise surgical manipulation are possible on one side, but on the other the risk of barotrauma may result in cases of proximal obstruction of the catheter.

[5, 6] Although jet ventilation is an established method to replace patients breathing during otorhinolaryngeal surgery, research is still required on efficient lung protective ventilation in order to provide adequate carbon dioxide (CO2) elimination, adequate oxygenation and in preventing ventilator induced lung injury. Jet ventilation techniques and access routes The TwinStream jet ventilator (C. Reiner Corp, Vienna, Austria) is routinely used for high-frequency jet ventilation (HFJV) or SHFJV in case of tubeless jet laryngoscopy (laryngeal micro- and laser surgery) and tracheoscopy. The device consists of two simultaneously operating ventilation units which can be adjusted separately. The driving pressure of the device is 1.5-3 bar and respiratory rates of 10-900 per min can be provided. Supraglottic jet laryngoscope In SHFJV, jet ventilation of normal frequency and high frequency is conducted simultaneously and enables ventilation at two different pressure levels through the steel jet laryngoscope. It is equipped with two jet nozzles, which are placed at the distal end of the jet laryngoscope, with the low-frequency jet stream passing the distal cannula, and the high-frequency jet stream at the proximal cannula. A third cannula at the tip of the laryngoscope allows ventilation pressure monitoring. The jet laryngoscope is introduced by the surgeon, for examining and operating structures within the laryngotracheal system. Supraglottic JV causes more laryngeal movement induced by disturbances through the high frequent inspiratory air passing the operating field compared to the subglottic jet ventilation. [9] Furthermore it leads to greater dryness of the vocal cords. During supraglottic SHFJV the escaping exhaled gases vent blood and secretion outward, reducing the risk of fluid aspiration and of displacing cells of any entity down to the tracheobronchial tree.

Advantages of SHFJV with the supraglottic inserted steel laryngoscope:

  • Unlimited surgical access and vision of the operating field
  • Laser resistant
  • Protection of the airway through the inherent 'auto-PEEP (positive endexpiratory pressure)' effect
  • Prevention of CO2 retention, lung alveolar collapse and improvement of the oxygen index Subglottic LaserJet Catheter Through the LaserJet catheter ventilation is performed only with HFJV. It is characterized by the delivery of small tidal volumes from a high pressure jet at very high frequencies (100-400) followed by passive expiration for a very short period before delivering the next jet, creating an "auto-PEEP".

The LaserJet catheter (C. Reiner Corp, Vienna, Austria) is made of polyterafluoroethylene and is non inflammable and provides a good micro anatomical overview of the operating structures [7,8,9] However, the LaserJet catheter is not laser resistant in regards of deformation damage (perforation) under direct exposure to a continuous laser beam. The use of the new 445 nm wavelength laser, the 'blue laser' eases the surgical performance by securing important laryngeal functionality even in advanced disease [3,4,10] While the exposure of the complete pathology is visualized and treated, the surrounding tissue is not dislocated or deformed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing elective micro-laryngotracheal surgery
  • Ventilation type: SHFJV and HFJV
  • Jet devices: Jet laryngoscope and LaserJet catheter
  • Age 18- 99 years.

排除标准

  • acute bleeding in the area of the larynx/trachea
  • infectious lung disease (e.g. tuberculosis)
  • inability to perform retroflexion of the head (laryngoscope cannot be positioned properly)
  • thoracic wall deformities
  • obesity, BMI >30kg/m2
  • implantable electronic devices (f.e. pacemaker, ICD)
  • emergency surgery
  • expected postoperative mechanical ventilation (Intensive Care Unit)

研究组 & 干预措施

Supraglottic jet ventilation

Active Comparator

Ventilation of the patient is performed over a steel laryngoscope or a thin catheter by means of jet ventilation (JV) using the TwinStream jet ventilator (C. Reiner Corp, Vienna, Austria). The driving pressure of the device is 1.5-3 bar and respiratory rates of 10-900 per min can be provided. In superimposed high frequency jet ventilation (SHFJV), jet ventilation of normal frequency and high frequency is conducted simultaneously and enables ventilation at two different pressure levels through the steel jet laryngoscope. It is equipped with two jet nozzles, which are placed at the distal end of the jet laryngoscope.

干预措施: EIT-measurement (Device)

Subglottic jet ventilation

Active Comparator

Subglottic HFJV is performed through the LaserJet catheter. It is characterized by the delivery of small tidal volumes from a high pressure jet at very high frequencies (100-400) followed by passive expiration for a very short period before delivering the next jet, creating an "auto-PEEP".

干预措施: EIT-measurement (Device)

结局指标

主要结局

Center of ventilation (COV)

时间窗: The EIT measurements will be recorded on arrival in the operating room (OR) under spontaneous breathing, during standardized, controlled mask ventilation and 5 minutes after supra- and subglottic JV.

Our primary aim is to determine whether supraglottic JV with the jet laryngoscope leads to a shift of the Center of Ventilation (COV) towards the ventral lungs compared to mask ventilation.

次要结局

  • ROI 1-4(The EIT measurements will be recorded on arrival in the operating room (OR) under spontaneous breathing, during standardized, controlled mask ventilation and 5 minutes after supra- and subglottic JV.)
  • ΔEELI(The EIT measurements will be recorded on arrival in the operating room (OR) under spontaneous breathing, during standardized, controlled mask ventilation and 5 minutes after supra- and subglottic JV.)
  • silent spaces(The EIT measurements will be recorded on arrival in the operating room (OR) under spontaneous breathing, during standardized, controlled mask ventilation and 5 minutes after supra- and subglottic JV.)
  • Special serum biomarkers for pulmonary inflammation and parenchyma damage(Blood will be drawn during mask ventilation, 5 minutes after supraglottic and 5 minutes after subglottic JV and at the end of surgery, before leaving to the recovery room for gas analysis and serum biomarkers.)
  • Blood gas analysis values(Blood will be drawn during mask ventilation, 5 minutes after supraglottic and 5 minutes after subglottic JV and at the end of surgery, before leaving to the recovery room for gas analysis and serum biomarkers.)

研究者

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

Marita Windpassinger M.D.

Principal Investigator

Medical University of Vienna

研究点 (1)

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