Assessing Recruitability for Flow Individualization in Patients Treated With Nasal High Flow: a Physiological Study (The iFLOW Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- To validate the correlation between the change in ROX index and the change in EELV
研究概览
简要总结
In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decreases work of breathing as compared to standard oxygen therapy by facemask.
The hypothesis is that this flow challenge (ROX index variation from 30 to 60L/min) could be used as a test for assessing changes in lung aeration, analyzed by the variation in end expiratory lung volume (ΔEELV), in patients treated with HFNC. It may allow to personalize the flow settings during HFNC. In this sense, an increase in EELV will be observed with higher flows in responders and, therefore, these participants may benefit from increasing the flow. In contrast, to increase the flow in non-responders (no significant increase in EELV with higher flows) increase the risk of patient self-inflicted lung injury (P-SILI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Adult patient admitted to the ICU requiring NHF due to AHRF that will be defined as an SpO2/FIO2 ratio <315
排除标准
- •Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation
- •Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h
- •Severe acidosis (pH ≤ 7.25)
- •Pregnant woman
- •Tracheotomised patient
- •Formalized ethical decision to withhold or withdraw life support
- •Patient under guardianship
- •Patient deprived of liberties
- •Patient already enrolled in the present study in a previous episode of acute respiratory failure
- •Patient who does not consent.
结局指标
主要结局
To validate the correlation between the change in ROX index and the change in EELV
时间窗: 20 minutes
Change in ROX is defined as the difference in ROX index (SpO2/FiO2/respiratory rate) between 2 flows. Change in EELV is the difference in End-Expiratory Lung Volume as determined by EIT.
次要结局
- To analyze the differences in respiratory rate at different flows(20 minutes)
- To analyze the differences in SpO2 at different flows(20 minutes)
- To assess the changes in lung homogeneity (by the variable global inhomogeneity index (GI)) measured by EIT at differents flows (30L/min, 45 L/min and 60L/min).(20 minutes)
- To assess the changes in aeration distribution (by the variable center of ventilation (CoV)) measured by EIT at different flows (30L/min, 45 L/min and 60L/min).(20 minutes)
- To analyze the differences in the FiO2 used at different flows(20 minutes)
- To analyze the differences in patient comfort at different flows, using the visual analogic scale (from 0 to 10)(20 minutes.)