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临床试验/NCT03797859
NCT03797859Unknown不适用

Apneic Oxygenation With Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) With Standardized Airway Management During General Anesthesia - an Observational Study of Blood Gas Dynamics of PaCO2, pH and PaO2.

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2019年1月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Respiratory acidosis

研究概览

简要总结

Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) denotes the use of high-flow humidified nasal oxygen system (for example Optiflow®) as an alternative ventilation modality for an anesthetized patient without spontaneous respiration. This method requires only basic airway management manoeuvres to keep the airway open and provides both stable longterm oxygenation as well as apneic ventialtion.

We plan to evaluate this methods physiological performance under standardized conditions of airway management by frequent, repeated arterial blood gas analyses.

详细描述

THRIVE is previously shown feasible as sole mode of ventilation in selected patients during general anaesthesia for minor laryngeal surgery for a limited time up to 30 minutes, where direct laryngoscopy was required and applied throughout the procedure. A stable oxygenation and a degree of ventilation was observed. However, a slowly developed respiratory acidosis was also observed over time.

Existing physiologic studies on high flow humidified nasal oxygen suggest that closed mouth breathing enhance the effects of the high flows of oxygen levels applied by increasing the airway pressures and thereby enhance gas exchange in the lungs. Currently, it is unclear whether the efficiency of THRIVE depends on the particular circumstances of airway management. Physiologic characterization of THRIVE performance under standardized conditions of airway management and under close monitoring by systematic analysis of blood gas dynamics over time during general anesthesia is needed.

We plan to study the blood gas dynamics during THRIVE apnea ventilation during general anesthesia, where the airway is managed only by jaw-thrust for up to 60 minutes. The patients will be closely monitored by repetitive arterial blood gasses to evaluate blood gas dynamics and development of respiratory acidosis. Desaturation or respiratory acidosis with pH under 7.15 and/or PaCO2-rise > 12 kPa will lead to cessation of THRIVE.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Adult (age over 18 years)
  • Elective surgery where intubation is not mandatory
  • The patient can understand the information about the study and give their informed written consent of participation

排除标准

  • ASA (American Society of Anaesthesiologists class) > 3
  • NYHA (New York Heart Association class) > 2
  • BMI > 30 kg/m2
  • Symptomatic respiratory disease
  • Symptomatic cardiac disease
  • Evidence of arteriosclerotic disease
  • Neuromuscular disease
  • Presumed or predicted difficult airway (SARI - Simplified Airway Risk Index score > 4)
  • Known or suspected nasal congestion/stenosis or catharalia

结局指标

主要结局

Respiratory acidosis

时间窗: Max. 60 minutes

Development of respiratory acidosis (pH \< 7.15 or paCO2 \> 12) over time on study

次要结局

未报告次要终点

研究者

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

Michael Seltz Kristensen

SENIOR CONSULTANT

Rigshospitalet, Denmark

研究点 (2)

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