Spontaneous Breathing and Progression of Lung Injury in Acute Respiratory Distress Syndrome Before Connection to Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Inflammation
研究概览
简要总结
Spontaneous breathing efforts in patients with respiratory failure connected to mechanical ventilation, has been associated with strong respiratory muscles activity. However, these mechanisms may will be present in patients with acute lung deseases who are breathing with no ventilatory support.
We hypothesize that spontaneous breathing during acute respiratory failure could induced lung inflammation and worsen lung damage. Hereby, the connection to a ventilatory support tool, may protect the lungs from spontaneous ventilation-induced lung injury.
To test our hypothesis, our aim is to determine the effects of spontaneous breathing in acute respiratory failure patients, on lung injury distribution; and to determine whether early controlled mechanical ventilation can avoid these deleterious effects by improving air distribution.
详细描述
Prospective clinical protocol in patients admitted to the ICU of the Hospital Clínico UC-Christus, Santiago de Chile, with diagnosis of acute hypoxemic respiratory failure, but who are still ventilating spontaneously.
Clinical data:
After hospital admission, patients who meet inclusion/exclusion criteria will be asked to consent to participate in the study protocol. Patients will be monitored conventionally according with hospital protocols (continuous ECG, SpO2, invasive arterial pressure, and intermittent arterial blood gases).
EIT Monitoring:
An EIT belt will be installed around the patient thorax connected to Enlight impedance tomography monitor (Dixtal, São Paulo, Brazil). EIT data will be recorded during periods of 3 minutes for offline analysis. Regional distribution of ventilation will be analyzed by dividing the image in four ROIs, each covering 25% of the ventro-dorsal distance encompassing the whole lung area. In addition we will estimate recruitment-derecruitment, and overdistention, regionally. In addition, pendelluft phenomena, and spatial patterns of regional deformation will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Acute respiratory symptoms for less than seven days
- •Acute hypoxemic respiratory failure defined by a ratio of partial pressure of arterial oxygen (Pao2) to Fio2 of 300 mm Hg or less, while breathing with standard oxygen mask at FiO2 > or equal to 30%
- •Increased work of breathing defined by either:
- •i. Respiratory rate > 25 / min, or ii. Signs of intercostal or supraclavicular retraction
- •Less than 24 hours since criteria 2 and 3 are met.
排除标准
- •Acute respiratory failure secondary to exacerbation of chronic respiratory disease or to cardiogenic pulmonary edema, PaCO2 > 45 mm Hg, decreased conscious level (Glasgow Coma Scale < 13), urgent need for endotracheal intubation, a decision not to resuscitate, and consent refusal.
结局指标
主要结局
Inflammation
时间窗: Plasma: At the time of enrollment and 48 hours post intubation. BALF: Immediately post intubation and 48-96 hours post intubation (only if it is required and indicated by the attending physician).
Cytokine analysis (TNF-α, IL-1β, IL-6, IL-8 and IL-10) in serum, bronchoalveolar lavage fluid (BALF) and tissue supernatants.
次要结局
- Pulmonary ventilation distribution(Every 6 hours from enrollment to intubation and after connection to mechanical ventilation each hour for the first 6 hours and then at 12, 18, 24 and 48 hours.)
研究者
Jaime Retamal
Medical Doctor
Pontificia Universidad Catolica de Chile