Physiological Effects on Respiratory Drive and Transpulmonary Pressure of a New Interface Combining High-flow Nasal Cannula and Cpap in Patients With Mild-to-moderate Acute Respiratory Distress Syndrome: a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22
- 主要终点
- Respiratory effort
研究概览
简要总结
This pilot physiologic randomized cross-over study was designed to investigate if, in patients with hARF, a new device combining high-flow oxygen through nasal cannula (HFNC) and continuous positive airway pressure (CPAP) reduces the respiratory effort, as compared to HFNC and CPAP alone (first outcome). Furthermore, the diaphragm activation, as assessed with ultrasound, gas exchange and patient's comfort among different settings will be assessed (secondary outcomes).
详细描述
Around 30% of patients admitted to the Intensive Care Unit (ICU) are affected by hypoxemic Acute Respiratory Failure (hARF). The primary supportive treatment in hypoxemic patients is oxygen therapy, which is commonly delivered through nasal prongs or masks. New devices, able to deliver high-flow gas through a nasal cannula (HFNC), have been recently made available. HFNC delivers heated and humidified gas up to 60 L/min, with a fraction of inspired oxygen (FiO2) ranging from 0.21 to 1, via a wide bore soft nasal prong. Warming and humidification of the inspired gas prevent the adverse effects of cool dry gases on the airway epithelium and facilitate expectoration. HFNC also washes out exhaled carbon dioxide (CO2) from the pharyngeal dead space. HFNC has been shown an effective means to deliver oxygen therapy in many clinical conditions.
In healthy subject during spontaneous unassisted breathing, end-expiratory pharyngeal pressure is about 0.3 and 0.8 cmH2O, with open and closed mouth, respectively. Compared to unassisted spontaneous breathing, HFNC generates greater pharyngeal pressure during expiration, while in the course of inspiration it drops to zero, which limits the effectiveness of HFNC in patients with lung edema and/or collapse. By recruiting lung atelectatic regions, reducing venous admixture and decreasing the inspiratory effort, continuous positive airway pressure (CPAP) is likely more effective in these instances. Compared to noninvasive ventilation by application of an inspiratory pressure support, CPAP offers several advantages, which include ease of use and lack of patient-ventilator asynchrony.
CPAP may be applied either through mask or helmet. This latter is better tolerated than facial masks and allows more prolonged continuous CPAP application. When applying CPAP by helmet, however, heating and humidification of the inhaled gas is problematic because of condensation of water inside the interface, so called "fog effect". Moreover, in patients receiving CPAP by helmet some re-breathing occurs.
To overcome these limitations and combine the beneficial effects of HFNC and CPAP, the investigators designed a new device combining HFNC and helmet CPAP.
Recently, this combination was shown to be capable to provide a stable CPAP and effective CO2 washout from the upper airways with negligible CO2 re-breathing. Nonetheless, because of the complex interplay between CPAP and HFNC, the amount of truly applied airway pressure, diaphragm function and temperature inside the helmet might be affected to some extent. In 14 adult healthy volunteers, we found that adding HFNC to CPAP (as referenced to CPAP), 1) did not importantly alter either the pre-set airway pressure during inspiration or temperature inside the helmet; 2) increased expiratory airway pressure proportionally to the flow administered by HFNC, but to a lower extent than HFNC alone (as referenced to spontaneous breathing); 3) determined only slight modifications of the respiratory drive (as assessed through diaphragm ultrasound), compared to CPAP alone, 4) did not cause "fog effect" inside the helmet and 5) did not worsen comfort. We therefore suggested that adding heated humidified air through nasal cannula at a flow of 30 L/min during CPAP would probably be the best setting to be applied in patients with hypoxemic acute respiratory failure.
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
- •presence of hypoxemic Acute Respiratory Failure, as defined by a respiratory rate greater than 25 breaths/min, an acute onset (within 1 week) of respiratory distress, an arterial oxygen tension (PaO2) and inspiratory oxygen fraction (FiO2) ratio (PaO2/FiO2) lower than 200 mmHg during HFNC, an evidence of bilateral pulmonary infiltrates in the chest X-ray or computed tomography scan, and an absence of history of chronic respiratory failure or moderate-to-severe cardiac insufficiency (New York Heart Association greater than grade 2 or left ventricular ejection fraction <50%).
排除标准
- •reduced level of consciousness, as indicated by a Glasgow Coma Scale < 12
- •severe respiratory distress (i.e. respiratory rate > 35 breaths/min)
- •hemodynamic instability, (i.e. systolic arterial pressure <90 mmHg or mean systolic pressure <65 mmHg despite fluid repletion)
- •need for vasoactive agents, i.e. vasopressin or epinephrine at any dosage, or norepinephrine >0.3 mcg/kg/min or dobutamine>5 mcg/kg/min
- •life-threatening arrhythmias or electrocardiographic signs of ischemia
- •acute respiratory failure secondary to neurological disorders, status asthmaticus, chronic obstructive pulmonary disease (COPD), cardiogenic pulmonary oedema
- •presence of tracheotomy
- •uncontrolled vomiting
- •more than 2 acute organ failures
- •body mass index >30 kg/m2
- •documented history or suspicion of obstructive sleep apnoea
- •contraindications to placement of a nasal-gastric feeding tube
- •facial anatomy contraindicating helmet or nasal cannula application
- •inclusion in other research protocols.
结局指标
主要结局
Respiratory effort
时间窗: After 30 minutes of treatment application
Inspiratory effort will be assessed as the negative inspiratory swing of the esophageal pressure
次要结局
- Diaphragm thickening fraction(After 30 minutes of treatment application)
- Arterial partial pressure of carbon dioxide (PaCO2)(After 30 minutes of treatment application)
- Patient's comfort(After 30 minutes of treatment application)
- Arterial partial pressure of oxygen (PaO2)(After 30 minutes of treatment application)
- Dynamic end-expiratory transpulmonary pressure(After 30 minutes of treatment application)
- Dynamic transpulmonary driving pressure(After 30 minutes of treatment application)
- Dynamic end-inspiratory transpulmonary pressure(After 30 minutes of treatment application)
- Diaphragm displacement(After 30 minutes of treatment application)
- Patient's Dyspnea(After 30 minutes of treatment application)
研究者
Federico Longhini
Prof
University Magna Graecia
