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临床试验/NCT05746949
NCT05746949已完成不适用

Comparison of the Effects of High Flow Nasal Cannula Oxygen and Jet Ventilation Techniques on Oxygenation in Endolaryngeal Surgery: A Randomized Controlled Trial

Istanbul University2 个研究点 分布在 2 个国家目标入组 36 人开始时间: 2023年2月18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
36
试验地点
2
主要终点
PaCO2 change

研究概览

简要总结

Endoscopic microsurgical procedures of the larynx (direct examination-bx, microlaryngeal resection) require the anesthesiologist and surgeon to work in the same area throughout the procedure, and while ventilation is provided during the procedure, small diameter endotracheal tubes are preferred to see the surgical area as easily as possible.

However, it is sometimes observed that even conventional endotracheal tubes of this diameter make surgery difficult by obstructing the view. On the other hand, apneic laryngoscopy techniques used in upper airway surgeries, such as microlaryngoscopy and laryngotracheal surgery, where the airway is shared by the anesthesiologist and surgeon, have been replaced by safer and controlled high-frequency jet ventilation applications due to the risk of hypoxemia and hypercapnia.

In recent years, oxygenation has come to the fore with Transnasal High Flow Insufflation (OptiflowTM - Fischer & Paykel Healthcare, Auckland, New Zealand), an apneic oxygenation method.

This randomized study aimed to compare the effects of high-flow nasal oxygen and jet ventilation on oxygenation in patients receiving general anaesthesia for endolaryngeal surgery.

详细描述

Endoscopic microsurgical procedures of the larynx (direct examination- bx, microlaryngeal resection) require the anesthesiologist and surgeon to work in the same area throughout the procedure, and while ventilation is provided during the procedure, small diameter endotracheal tubes are preferred to see the surgical area as easily as possible.

However, it is sometimes observed that even conventional endotracheal tubes of this diameter make surgery difficult by obstructing the view.

On the other hand, apneic laryngoscopy techniques used in upper airway surgeries, such as microlaryngoscopy and laryngotracheal surgery, where the airway is shared by the anesthesiologist and surgeon, have been replaced by safer and controlled high-frequency jet ventilation applications due to the risk of hypoxemia and hypercapnia. In recent years, oxygenation has come to the fore with Transnasal High Flow Insufflation (OptiflowTM - Fischer & Paykel Healthcare, Auckland, New Zealand), an apneic oxygenation method. High-flow nasal cannula has been used, especially in critically ill patients. It is a system that delivers oxygen with high flow (up to 70 L/min) consisting of an air-oxygen mixer, an active heated humidifier, a single heated circuit and a nasal cannula.

Heated and humidified high-flow oxygen prolongs the time of preoxygenation and apneic oxygenation. In both jet ventilation and optiflow ventilation, gas exchange parameters of the patient can be measured by pulse oximetry, capnography, arterial blood gas or transcutaneous blood gas measurements. Determining the CO2 status (end-tidal CO2-ETCO2) in both techniques is quite difficult due to large leaks in the exhaled gas. Determining the patient's CO2 level is valuable as it shows the gas exchange. Ventilation settings are made according to this parameter. Arterial blood gas measurements can be performed for this purpose, but their invasiveness is limiting. An alternative method for assessing CO2 status is the nasal ETCO2 measurement. Evaluation of ventilation and oxygenation with nasally applied ETCO2 monitoring is a simple application that will bring patient safety to higher levels. In evaluating the adequacy of ventilation, basal ETCO2 values should be taken during the patients spontaneous breathing. This value should be compared with the values obtained during jet ventilation and transnasal high-flow oxygenation.

This randomized clinical study aims to compare the effects of high-flow nasal oxygen and jet ventilation on oxygenation in patients receiving general anaesthesia for endolaryngeal surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients with ASA I-II status
  • Patients who will receive general anesthesia for endolaryngeal surgery
  • >18 years old
  • Volunteer to participate in the study

排除标准

  • <18 years old
  • MI (EF<%50)
  • Arrhythmia
  • Peripheral vascular disease
  • Cerebrovascular disease
  • Electrolyte disorder
  • Severe COPD
  • Chronic hypoxia
  • BMI>35 kg/m2
  • Refusal to participate in the study

结局指标

主要结局

PaCO2 change

时间窗: Intraoperative

PaCO2 change (before preoxygenation, before induction, every 5 minutes after induction) was recorded by arterial blood gas analysis.

Ph change

时间窗: Intraoperative

Ph changes (before preoxygenation, before induction, every 5 minutes after induction) were recorded by arterial blood gas analysis

次要结局

  • Surgical satisfaction questionnaire(Intraoperative)
  • Arterial ETCO2 values(Intraoperative)
  • Anesthesia duration(Intraoperative)
  • Nasal ETCO2 values(Intraoperative)
  • Surgery time(Intraoperative)
  • Respiratory complications(Intraoperative)

研究者

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

Demet Altun

attending anesthesiologist

Istanbul University

研究点 (2)

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