NL-OMON48534招募中4 期
Prone and Oscillation Pediatric Clinical Trial - PROSpect
ational Heart, Lung and Blood Institute0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17(—)
入选标准
- •Pediatric patients >=2 weeks of age (>=42 weeks post gestational age) and <18 years of age*Intubated and mechanically ventilated with severe PARDS for <48 hours per PALICC guidelines(chest imaging consistent with acute pulmonary parenchymal disease and OI >=16 or OSI >=12.3). We require two consecutive blood gases meeting severe PARDS criteria (separated by at least 4 hours during which time the clinical team is working to recruit lung volume and optimize the patient*s hemodynamic status per PALICC guidelines).
排除标准
- •Perinatal related lung disease
- •Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis
- •Respiratory failure explained by cardiac failure or fluid overload, cyanotic heart disease, cardiomyopathy
- •Unilateral lung disease*Primary pulmonary hypertension
- •Status asthmaticus
- •Obstructive airway disease (e.g.,bronchiolitis or disease states characterized by either: hypercapnia with FiO2< 0.30, and/or evidence of increased resistance visible on the flow -time scalar, and/or presence of intrinsicPEEP)*Bronchiolitis obliterans
- •Post Hematopoietic Stem Cell transplant
- •Post lung transplant
- •Home ventilator (including noninvasive) or home oxygen dependent
- •Neuromuscular respiratory failure
- •Critical airway (e.g., post laryngotracheal surgeryor new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass)
- •Facial surgeryor trauma in previous 15 days
- •Headtrauma, intracranial bleeding
- •Unstable spine, femur or pelvic fractures
- •Acute abdominal process
- •Obesity (2w-2y: weight-for-height z-score >+3 WHO; >2y BMI z score >+2 WHO)
- •Received either prone positioning or HFOV with current illness, supported on ECMO
- •Previously enrolled in current study
- •Family/medical team not providingfull support (patient treatment considered futile)
- •Enrolled in any other critical care interventional clinical trial concurrently
- •Known pregnancy
研究者
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