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临床试验/NL-OMON48534
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

发起方
ational Heart, Lung and Blood Institute

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