Pediatric Acute Respiratory Distress Syndrome (ARDS) Management (PARMA) Trial
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Sustained Resolution of Hypoxemia
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is a serious and potentially life-threatening lung condition that can affect children. Currently, ventilator settings commonly used in treatment are based on approaches developed for adults, and it remains unclear whether these settings are equally effective for children. Because children's bodies respond differently than adults', it is important to determine the most effective ventilator strategies specifically for pediatric patients. This study will compare two different ventilator approaches in children with ARDS to identify which method provides the greatest benefit. The findings will also help inform the design of a larger study in the future.
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
- 2 Weeks 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 2 weeks (> 38 weeks corrected gestational age) and < 18 years (not yet had 18th birthday)
- •acute (≤ 7 days of risk factor) respiratory failure requiring invasive mechanical ventilation
- •ventilated with endotracheal tube or tracheostomy for ≤ 7 days from risk factor onset
- •hypoxemia defined as PaO2/FIO2 (measurement of the amount of oxygen dissolved in the blood plasma/concentration of inhaled oxygen) > 300 (or SpO2/FIO2 (measurement of the percentage of hemoglobin in your blood that is carrying oxygen/concentration of inhaled oxygen) > 315 on Positive End-Expiratory Pressure (PEEP) ≥ 5 cmH2O (rate of pressure delivery) on two consecutive measurements 4 hours apart and sustained at the time of consent and randomization
- •bilateral opacities on chest radiograph as determined by radiologist, clinical attending, or PI
排除标准
- •hypoxemia caused primarily by hydrostatic pulmonary edema from heart failure or fluid overload
- •non-palliated or unrepaired cyanotic congenital heart disease
- •ventilated via tracheostomy at baseline prior to acute illness
- •obstructive airway disease determined to be the primary cause of respiratory failure
- •severe moribund state not expected to survive > 72 hours
- •any limitations of care at time of screening
- •escalation to high frequency oscillatory ventilation or extracorporeal support (i.e., meeting PARMA protocol failure criteria) at time of screening
- •previous enrollment in this study
研究组 & 干预措施
Low Driving Pressure Mechanical Ventilation
A participant who is already on the breathing machine will have the driving pressure set to 15 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do.
干预措施: Low Driving Pressure Mechanical Ventilation (Other)
High Driving Pressure Mechanical Ventilation
A participant who is already on the breathing machine will have the driving pressure set to 25 cmH2O (rate of pressure delivery). All other standard clinical care for this participant will stay the same based on what their clinical team chooses to do.
干预措施: High Driving Pressure Mechanical Ventilation (Other)
结局指标
主要结局
Sustained Resolution of Hypoxemia
时间窗: Up to 672 hours
The primary outcome of PARMA is time (in hours) per participant to sustained resolution of hypoxemia, defined as being alive with PaO2/FIO2 (measurement of the amount of oxygen dissolved in the blood plasma/concentration of inhaled oxygen) \> 300 (or SpO2/FIO2 (measurement of the percentage of hemoglobin in your blood that is carrying oxygen/concentration of inhaled oxygen) \> 315) on two consecutive measurements 4 hours apart. This outcome is censored at 28 days (672 hours).
次要结局
- Imaging (Electrical Impedance Tomography (EIT)): Overdistension(Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.)
- Imaging (Electrical Impedance Tomography (EIT)): Center of Ventilation(Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.)
- Clinical End Point: Pediatric ICU discharge(From enrollment up to pediatric ICU discharge, no longer than 90 days)
- Imaging (Electrical Impedance Tomography (EIT)): Lung recruitment(Once from time of enrollment to randomization, once within 8 hours post-randomization and once within 24-72 hours after randomization.)
- Clinical End Point: all-cause mortality at 28 days(From enrollment up to hospital discharge, no longer than 28 days.)
- Clinical End Point: all-cause mortality at 90 days(From enrollment up to hospital discharge, no longer than 90 days.)
- Clinical End Point: Hospital Discharge(From enrollment up to hospital discharge, no longer than 90 days.)
- Clinical End Point: Primary Cause of Death(From enrollment up to hospital discharge, no longer than 90 days.)
- Clinical End Point: Ventilator Free Days(From enrollment up to hospital discharge, no longer than 28 days.)
- Clinical End Point: New Oxygenation- or Ventilator-dependency(From enrollment up to hospital discharge, no longer than 90 days.)
- Safety Endpoint: pneumothorax requiring chest tube(From enrollment up to hospital discharge, no longer than 90 days.)
- Safety Endpoint: other air leak not requiring chest tube(From enrollment up to hospital discharge, no longer than 90 days.)
- Safety Endpoint: ventilator-associated pneumonia(From enrollment up to hospital discharge, no longer than 90 days.)
- Safety Endpoint: new or progressive multiple organ dysfunction syndrome(From enrollment up to hospital discharge, no longer than 90 days.)