The Effects of Different Flow Settings on Lung Impedance Using Two New HFNC Devices: A Randomized Crossover Study on Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in End-expiratory Lung Impedance From Baseline Measured by Electrical Impedance Tomography (EIT)
研究概览
简要总结
This prospective, randomized crossover trial will enroll adult healthy volunteers. Initially, the subject's peak inspiratory flow will be measured using a mask connected with a respiratory monitor. Subsequently, the volunteers will undergo HFNC treatment at different flow settings while their peak inspiratory flow will be continuously monitored. The primary outcome of this study is the lung aeration with different flow settings. Secondary outcomes include the lung aeration with different devices, subject's comfort at different flow settings, and the correlation between the subject's peak inspiratory flow measured by HFNC and by a mask connected with a respiratory monitor.
详细描述
Background: High-flow nasal cannula (HFNC) is a device that can reduce the work of breathing (WOB) and improve oxygenation by providing a flow that matches or exceeds patient's peak inspiratory flow during tidal breathing. Despite its widespread use, there remains a lack of consensus regarding the optimal flow settings. Two new HFNC devices that can provide information regarding patient's peak tidal inspiratory flow breath by breath are recently available, which might help guide set and titrate the flow settings. This study aims to investigate the effects of different flow settings on lung impedance in a cohort of healthy volunteers by using the two new HFNC devices.
Methods: This prospective, randomized crossover trial will enroll adult healthy volunteers. Initially, the subject's peak inspiratory flow will be measured using a mask connected with a respiratory monitor. Subsequently, the volunteers will undergo HFNC treatment at different flow settings while their peak inspiratory flow will be continuously monitored. The primary outcome of this study is the lung aeration with different flow settings. Secondary outcomes include the lung aeration with different devices, subject's comfort at different flow settings, and the correlation between the subject's peak inspiratory flow measured by HFNC and by a mask connected with a respiratory monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between 21-65 years old
排除标准
- •Chronic pulmonary diseases, including COPD, interstitial lung disease, cystic fibrosis, etc.
- •Uncontrolled asthma;
- •Pregnancy
- •Subjects who have cold/flu symptoms (sore throat, runny nose, fever, chills, coughing)
- •Nose abnormalities that can affect the functionality of the nasal prongs
结局指标
主要结局
Change in End-expiratory Lung Impedance From Baseline Measured by Electrical Impedance Tomography (EIT)
时间窗: Up to 4 hours
End-expiratory lung impedance (EELI) was measured continuously using electrical impedance tomography (EIT). For each flow-setting condition, EELI values were averaged over a stable 1-minute period. The outcome represents the change in EELI (in arbitrary impedance units) from each participant's baseline measurement prior to intervention. Positive values indicate an increase in end-expiratory lung volume compared to baseline, while negative values indicate a decrease. EIT impedance units are dimensionless and device-specific and are used to represent relative changes in ventilation and lung volume.
次要结局
- Changes in Respiratory Rates Compared to Baseline(Up to 4 hours)
- Subject's Comfort Level(Up to 4 hours)