Comparative Study Between Airway Pressure Release Ventilation and Bi-level Positive Airway Pressure Ventilation in Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- partial pressure of oxgyen in arterial blood
研究概览
简要总结
To evaluate whether early use of airway pressure release ventilation would improve oxgyenation , improve lung compliance and shorten the time of mechanical ventilation compared to BIPAP ventilation in ARDS patients
详细描述
Acute respiratory distress syndrome (ARDS) is an extremely dangerous lung condition that leads to low blood oxygen levels, and is commonly caused by sepsis, pneumonia, aspiration, and trauma. Despite great improvements in mechanical ventilation in recent years, the mortality rate of ARDS is still high. Low tidal volume ventilation (LTVV), optimum positive end-expiratory pressure, permissive hypercapnia, lung recruitment, and the prone position are common treatments for ARDS .
Lung recruitment maneuvers (LRMs) are a common element of the "open lung" approach to lung-protective ventilation. Given that atelectasis increases alveolar stress and strain during tidal ventilation, LRMs may mitigate ventilator-induced lung injury (VILI) and reduce the considerable risk of death for patients with ARDS. However, the transient application of high airway pressures may impair cardiovascular function and traumatize the pulmonary epithelium (barotrauma). Consequently, the use of LRMs is controversial .
APRV and BIPAP are modes of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. Both modes are pressure-limited. Ventilation occurs via the time-cycled switching between two set pressure levels .
Bilevel positive airway pressure is a partial support mode that employs pressure-controlled, time-cycled ventilation set at two levels of continuous positive airway pressure (CPAP) with unrestricted spontaneous breathing. Which can occur at any phase of the mechanical ventilatory cycle. Bilevel positive airway pressure is able to modulate the inspiratory effort by modifying the frequency of controlled breaths .
In traditional biphasic ventilation, the inspiratory to expiratory ratio is not inverse. This ratio often distinguishes biphasic ventilation from APRV. Ventilator parameters set in this mode include the inspiratory pressure limit (Phigh), inspiratory time (Thigh), PEEP level (Plow), rate, and fraction of inspired oxgyen (FiO2). On some ventilators, pressure support may be added to augment the patient's spontaneous breaths .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all ARDS criteria (according to Berlin definition).
- •Patients who had received endotracheal intubation and mechanical ventilation for <48h prior to inclusion.
排除标准
- •Age below 18 years and above 65 years.
- •Presence of significant chronic pulmonary disorder (chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, suppurative lung disease or diffuse alveolar hemorrhage) or documented barotrauma.
- •Presence of cardiac disorder (rheumatic or ischemic heart disease).
- •Presence of intracranial hypertension (suspected or confirmed).
- •History of malignancies or patients on immunosuppressive drugs.
- •Pregnancy or presence of neuromuscular disorder known to prolong intubation.
研究组 & 干预措施
APRV
The settings for APRV were:
- High airway pressure (Phigh) set at the last plateau airway pressure (Pplat), not to exceed 30 cmH2O and low airway pressure (Plow) set at (5 cmH2O).
- The release phase (Tlow) setting adjusted to terminate the peak expiratory flow rate to ≥ 50%.
- Release frequency of 10-14 cycles/min.
干预措施: mechanical ventilation (MV) (Other)
BiPAP
The settings for BiPAP were:
- Ti (inspiratory time) is set according to inspiratory time constant.
- Optimum PEEP is set according to FiO2 to achieve the goal of SpO2≥90%.
- FiO2 is set to achieve the goal of SpO2≥ 90%.
干预措施: mechanical ventilation (MV) (Other)
结局指标
主要结局
partial pressure of oxgyen in arterial blood
时间窗: an average of 6 months
To evaluate whether early use of airway pressure release ventilation (APRV) would improve oxygenation (as assessed by partial pressure of oxygen in the arterial blood (PaO2)).
次要结局
- Number of days on mechanical ventilation(Up to 6 months)