The Physiological Effects of Different Non-invasive Respiratory Support in Patients With Acute Hypoxemic Respiratory
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Magnitude of Pendelluft
研究概览
简要总结
Patients with acute hypoxemic respiratory failure (AHRF) typically present with pathophysiological alterations characterized by the coexistence of respiratory dysfunction and hypoxemia. Respiratory dysfunction leads to dyspnea, increased work of breathing, use of accessory respiratory muscles, and hypercapnia, while gas exchange impairment results in hypoxemia. Studies have shown that hypercapnia, acidosis, and hypoxemia can all enhance inspiratory effort, which further increases negative intrathoracic pressure. In these patients, regional differences in airway resistance and lung compliance are often present, causing redistribution of air within the lungs. This redistribution manifests as gas movement from non-dependent to dependent regions, known as "pendelluft," which amplifies regional alveolar strain and ventilation heterogeneity. This phenomenon becomes more pronounced during noninvasive respiratory support when spontaneous breathing is preserved.
Noninvasive respiratory support strategies mainly include high-flow nasal oxygen (HFNO), noninvasive positive pressure ventilation (NIV), and continuous positive airway pressure (CPAP). HFNO delivers high-flow gas through nasal cannulas, generating a certain level of positive end-expiratory pressure (PEEP) and flushing out anatomical dead space to improve gas exchange, thereby reducing inspiratory effort, lowering the work of breathing, and enhancing oxygenation. NIV, typically using pressure support ventilation (NIV-PSV), is a patient-triggered, pressure-targeted mode that provides inspiratory positive pressure above PEEP. By augmenting tidal volume and reducing inspiratory effort, NIV improves gas exchange; however, leaks may limit the effective delivery of PEEP, and full inspiratory synchronization can increase transpulmonary driving pressure and tidal volume. CPAP, by contrast, delivers a constant positive pressure during both inspiration and expiration. Compared with HFNO, CPAP generates higher PEEP, which facilitates alveolar recruitment and more effectively improves oxygenation. Relative to NIV, CPAP may reduce transpulmonary driving pressure and tidal volume.
Different noninvasive respiratory support strategies exert varying effects on respiratory drive and regional lung strain, leading to differences in the occurrence and magnitude of pendelluft. Physiological studies have suggested that CPAP may offer greater benefits in improving oxygenation and reducing inspiratory effort; however, whether it can mitigate the occurrence and extent of pendelluft remains uncertain. Therefore, this study was conducted to visualize and quantitatively assess pendelluft in real time using electrical impedance tomography (EIT), aiming to verify whether CPAP has a superior effect in reducing pendelluft in patients with AHRF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years;
- •PaO₂/FiO₂ ≤ 300 mmHg or SpO₂/FiO₂ ≤ 315 (with SpO₂ ≤ 97%);
- •Requiring one of the following respiratory supports:
- •Noninvasive positive pressure ventilation with PEEP ≥ 5 cmH₂O, or
- •High-flow nasal oxygen therapy with a flow rate ≥ 30 L/min, or
- •Conventional oxygen therapy with an oxygen flow ≥ 10 L/min, where FiO₂ is calculated using the formula: FiO₂ = 0.21 + (oxygen flow rate × 0.03).
排除标准
- •Received CPAP or NIV for more than 24 hours prior to screening.
- •Received invasive mechanical ventilation during the current hospitalization.
- •Presence of chronic underlying pulmonary disease, or PaCO₂ ≥ 45 mmHg.
- •Presence of cardiogenic pulmonary edema.
- •Hemodynamic instability, defined as systolic blood pressure < 90 mmHg or norepinephrine-equivalent dose > 0.3 µg/kg/min.
- •Impaired consciousness (GCS ≤ 12).
- •Patients requiring urgent intubation, including those with respiratory or cardiac arrest, apnea with loss of consciousness or gasping, or severe hypoxemia (defined as SpO₂ < 90% despite 100% oxygen).
- •Contraindications to NIV: cardiac or respiratory arrest, coma, untreated pneumothorax, uncontrollable vomiting, upper airway obstruction, hematemesis or severe facial trauma, or thoracic/abdominal surgery within the past 7 days.
- •Contraindications to EIT: implanted cardiac pacemaker, unstable spinal injury or fracture, or open chest trauma.
- •Refusal of endotracheal intubation.
- •Pregnancy.
研究组 & 干预措施
CPAP group
Patients will receive continuous positive airway pressure
干预措施: Continuous Positive Airway Pressure (Device)
NIV group
Patients will receive non-invasive ventilation
干预措施: Non-invasive ventilation (Device)
HFNO group
Patients will receive HFNO
干预措施: High-flow nasal oxygen (Device)
结局指标
主要结局
Magnitude of Pendelluft
时间窗: during the first 48 hours
magnitude of Pendelluft using a software based on electrical impedance tomography monitoring
次要结局
- Pao2/FiO2(during the first 48 hours)
- Occlusion pressure at 100 ms (P0.1)(during the first 48 hours)
- Occluded inspiratory airway pressure (Pocc)(during the first 48 hours)
- center of ventilation(during the first 48 hours)
- pH(during the first 48 hours)
- Partial pressure of oxygen (PaO2)(during the first 48 hours)
- Partial Pressure of Carbon Dioxide (PaCO2)(during the first 48 hours)
- RVD(during the first 48 hours)
研究者
Ling Liu
Principal Investigator
Southeast University, China
