A PILOT RANDOMIZED CONTROLLED TRIAL COMPARING â??AIRWAY PRESSURE RELEASE VENTILATIONâ?? AND â??CONVENTIONAL LUNG-PROTECTIVE VENTILATIONâ?? IN CHILDREN WITH EARLY ACUTE RESPIRATORY DISTRESS SYNDROME - APRiCE

Indian Council Of Medical Research ICMR New Delhi0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Children aged 1 month- 12 years, who are intubated and mechanically ventilated with the following criteria of Acute Respiratory Distress Syndrome:
•1.Acute presentation within 1 week of a known clinical insult or new/ worsening respiratory symptoms
•2.Bilateral opacities on chest imaging â?? not fully explained by effusions, lobar/lung collapse, or nodules
•3.Respiratory failure is not fully explained by cardiac failure or fluid overload (Echocardiographic assessment to exclude hydrostatic edema)
•4.Impaired oxygenation with PaO2/ FiO2 ratio less than 300 or Oxygenation Index greater than 5.3

•Children with the following conditions would be excluded:
•(i)Greater than 24 hours since diagnosis of ARDS
•(ii)Co-existing raised intra-cranial pressure/ any other condition necessitating use of high dose of sedation (likely to suppress spontaneous breathing)
•(iii)Radiologically confirmed air leak prior to randomization â?? Pneumothorax/ Pulmonary interstitial Emphysema
•(iv)Clinical evidence of significant airway obstruction/ severe bronchospasm / reactive airway disease
•(v)Have received mechanical ventilation for more than 72 hours (before meeting inclusion criteria 1-5)
•(vi)Symptomatic or uncorrected congenital heart disease or a right to left intra-cardiac shunt
•(vii)Any underlying condition that is likely to impair spontaneous respiratory drive/ efforts (Eg: Brainstem dysfunction, neuromuscular paralysis)
•(viii)Underlying chronic diseases (Eg: Cystic fibrosis, Chronic lung disease, etc)

发起方

Indian Council Of Medical Research ICMR New Delhi