Comparative Study of the Physiological Effects of High Flow Nasal Cannula and Non-invasive Ventilation in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- End expiratory nasopharyngeal pressure (NP)
研究概览
简要总结
Respiratory failure is characterized by low levels of oxygen and high levels of carbon dioxide in the blood which causes difficulty breathing. The management of patients with respiratory failure aims at improving oxygenation and changing the effort required to breathe. Mechanical ventilation is a life-saving treatment but may be associated with a high mortality rate, prolonged stay in the intensive care unit (ICU), and infection. Oxygenation techniques to avoid mechanical ventilation include standard oxygen therapy, continuous positive pressure (CPAP), and high-flow nasal cannula oxygen therapy (HFNC). CPAP consists of delivering oxygen through a mask. As compared to standard oxygen therapy, CPAP can promote lung recruitment leading to improved oxygenation and the effect in work of breathing in patients with respiratory failure. Conversely, high-flow nasal cannula oxygen therapy (HFNC) delivers oxygen through nasal prongs. Oxygen is heated and humidified and can be delivered at different flows (from 10 - 60 L/min). As compared to standard oxygen therapy, HFNC can promote some lung recruitment leading to mofiy oxygenation and work of breathing. Therefore, the present study will have 2 phases:
Phase 1:Comparison of the physiological effects of different flows of HFNC to CPAP in healthy volunteers. The investigators hypothesized that the physiological effects of HFNC in the nasopharynx are comparable to that of CPAP at 4 cm H2O.
Phase 2: Comparison of the physiological effects of different nasal interfaces of HFNC (Standard cannula vs. Asymmetrical cannula vs. Single-nostril adapted cannula) in healthy volunteers. The investigators hypothesized that the physiological effects of HFNC in the nasopharynx are comparable to that of CPAP at 4 cm H2O. It was hypothesized that asymmetrical which is the cannula that has a higher cross-sectional area generates higher nasal pharyngeal pressure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Healthy volunteers ≥ 18 y-o,
- •No evidence of acute or chronic cardiopulmonary disease
排除标准
- •Active epistaxis, sinus problem, nasal trauma, or deviated septum that would preclude the nasopharyngeal catheter insertion,
- •Pregnancy, clinical evidence of respiratory illness, history of respiratory disease, body mass of over 50 kg/m2, ribcage malformation,
- •Cardiac pace maker or implantable cardioverter-defibrillator according to EIT manufacturer,
- •Allergy to topical lidocaine,
- •Claustrophobia that would preclude the use of CPAP or HFNC.
结局指标
主要结局
End expiratory nasopharyngeal pressure (NP)
时间窗: 5min
The primary endpoint is to compare the end expiratory nasopharyngeal pressure (NP) of high flow nasal cannula (HFNC) among the 3 different nasal cannulas (Symmetrical, Asymmetrical, Single-nostril adapted).
次要结局
- Change in end-expiratory lung impedance(5 minnutes)
- Change in physiologic variables of airway pressure at different flows of HFNC (20, 40, and 60 L/min) and CPAP (4 cmH20). In the phase#2; HFNC 2, and 50 L/min.(5 minutes)
- Dead-space washout in the upper airways(5 minutes)