Assessing Ventilator Safety in Patients on Pressure-Support Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Airway Occlusion Test (AOC)
研究概览
简要总结
ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation. We will describe the relationship between three different assessment methods for risk of self-induced lung injury and compare them to a gold standard measurement.
详细描述
Ventilator-induced lung injury (VILI) is known to cause significant morbidity and mortality in patients with acute respiratory failure. Most studies on VILI have involved the effects of inappropriate (often excessive) mechanical ventilator settings. More recently, it has been noted that similar lung damage can be caused by large, patient generated, uncontrolled tidal volumes and driving pressures, which has been termed "self-induced lung injury," or SILI.
Pressure-support ventilation (PSV) is a common mechanical ventilation mode often used in patients with active inspiratory efforts to help reduce patient inspiratory work and improve comfort. PSV effectively allows spontaneously breathing patients to determine their breath flow-rate and breath duration, eliminating flow and cycle dyssynchrony. However, pressure support ventilation does not allow for physicians to control tidal volume or driving pressure. The risk of SILI may thus be increased with PSV.
Several different methods have been proposed to address these challenges. However, to date none of these methods have been compared to assess for concordance in their ability to indicate an increased risk of self-induced lung injury. ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Adult patients age ≥18 years with acute respiratory failure receiving invasive mechanical ventilation
- •Managed in pressure-support mode of ventilation
排除标准
- •Actively undergoing a spontaneously awakening trial or SAT
- •Patient or surrogate is unable to provide informed consent
- •Currently pregnant
- •Currently incarcerated
- •Acute exacerbation of an obstructive lung disease
- •Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe
- •Esophageal, gastric or duodenal surgical procedures within the last 6 months
结局指标
主要结局
Airway Occlusion Test (AOC)
时间窗: Study day 1
Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver. The Vyaire SmartCath adult nasogastric tube with esophageal balloon was used to measure esophogeal pressure change during airway occlusion maneuver.
Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo)
时间窗: Study day 1
Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3)
时间窗: Study day 1
Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
Airway Occlusion Test (AOC)
时间窗: Study day 1
Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver. The Vyaire SmartCath adult nasogastric tube with esophageal balloon was used to measure esophogeal pressure change during airway occlusion maneuver.
Respiratory System Driving Pressure Measured During Volume Control Breath.
时间窗: Study day 1
Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
Transpulmonary Driving Pressure Measured During Volume Control Breath.
时间窗: Study day 1
Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.
次要结局
- Ventilator Free Days(Index hospitalization (up to 28 days))
- Duration of Mechanical Ventilation(Index hospitalization (up to 28 days))
- Ventilator Free Days(Index hospitalization (up to 28 days))
- In-hospital Survival(Index hospitalization (up to 28 days))
- Duration of Intensive Care Unit Admission(Index hospitalization (up to 28 days))
- Duration of Hospital Admission(Index hospitalization (up to 28 days))