Physiological Comparison of High-flow Nasal Cannula, Helmet Pressure Support Ventilation and Continuous Positive Airway Pressure During Acute Hypoxemic Respiratory Failure: a Randomized Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Inspiratory effort
研究概览
简要总结
The investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (PSV) and continuous positive airway pressure (CPAP) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure
详细描述
Setting: 21-bed general ICU, emergency room of the Emergency department (ED), Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy..
Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
Each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. An ABG will be then collected and PaO2/FiO2 ratio computed: given the high flows used, actual FiO2 will be approximated to the set one.
Nonhypercapnic patients with a PaO2/FiO2≤200 mmHg will be enrolled. In the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing PaO2/FiO2≤300 and >200 mmHg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently.
Enrolled patients will receive all the interventions (helmet CPAP, PSV and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the ICU with de novo acute respiratory failure will be assessed for the enrolment.
- •Patients will be considered eligible whether all the following inclusion criteria are met:
- •Respiratory rate>25 bpm.
- •PaO2/FiO2 ≤200 in the supine position, measured after 15 minutes of high flow treatment with face mask (60 l/min, temperature of the humidification chamber set at 37°C, FiO2 set to achieve a SpO2 >92% and <98%). Given the use of the high flows, nominal FiO2 will be considered a reliable estimate of the actual one.
- •PaCO2 <45mmHg
- •Absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency.
- •Written informed consent
排除标准
- •Exacerbation of asthma or chronic obstructive pulmonary disease;
- •Cardiogenic pulmonary oedema;
- •Haemodynamic instability (Systolic blood pressure <90 mmHg or mean arterial pressure <65 mmHg) and/or lactic acidosis (lactate >5 mmol/L) and/or clinically diagnosed Shock
- •Metabolic Acidosis (pH <7.30 with normal- or hypo-carbia);
- •Glasgow coma scale <13;
- •Recent head surgery or anatomy that prevent the application of helmet or nasal cannula to patient's face.
结局指标
主要结局
Inspiratory effort
时间窗: 40 minutes
The negative deflection in esophageal pressure during inspiration
Tidal volume
时间窗: 40 minutes
The tidal change in lung impedance, assessed by electrical impedance tomography
次要结局
- Respiratory system dynamic compliance(40 minutes)
- Global impedance-derived End-expiratory lung volume(40 minutes)
- Oxygenation(40 minutes)
- Tidal volume distribution(40 minutes)
- Carbon dioxide(40 minutes)
- Regional impedance-derived lung dynamic strain(40 minutes)
- Respiratory rate(40 minutes)
- Dyspnea(40 minutes)
- Global impedance-derived lung dynamic strain(40 minutes)
- Comfort(40 minutes)
- Regional impedance-derived End-expiratory lung volume(40 minutes)
- Dynamic transpulmonary driving pressure(40 minutes)
- Pendelluft(40 minutes)
- Work of breathing(40 minutes)