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临床试验/NCT01450527
NCT01450527已完成不适用

Etiology and Outcomes of Acute Respiratory Distress Syndrome in Medical ICU in AIIMS

All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
28-day mortality

研究概览

简要总结

This is a prospective observational study done to know the etiology and outcomes of Acute Respiratory Distress Syndrome.

详细描述

The study will be a prospective observational study and 64 patients with ARDS will be recruited . Written informed consent will be taken prior to inclusion of study. Study will be conducted in Medical ICU (C2 ICU) of AIIMS. Based on medical history and physical examination, radiology, biochemical and microbiological investigations etiology of ARDS will be decided.Sample will be taken at te eime of admission for estimation of inflammatory markers hsCRP,IL-1.IL-6,TNF ,Procalcitonin.From the available variables APACHE II, Sequential organ failure assessment score (SOFA), Simplified acute physiological score (SAPS)II and 3 will be calculated to assess the severity of ARDS.All patients will be given mechanical ventilation using the protocol followed by the ARDS Network low-tidal volume ventilation strategy.The data will be registered on ICU admission and there after every 24 hr. Day 0 will be defined as the interval from the time of ICU admission to 8:00 am the next day .Every day data will be recorded at a fixed time at 9 am. It will include Tidal volume Vt (ml/kg),respiratory rate/min, Minute ventilation(l/min),FiO2,PaO2/FiO2,Inspiratory flow(I:E), Ppeak (cm of H2O),Static respiratory compliance(ml/cm of water).Plateau pressure (Pplat), Peak end expiratory pressure (PEEP).Patient will be monitored throughout the course of illness and the outcome of ARDS will be assessed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects fulfilling the criteria of ARDS according to American-European consensus definition
  • Admitted in medical ICU(CII/CU)
  • No known previous lung pathology e.g. bronchiectasis, Interstitial lung disease

排除标准

  • HIV positive serology.
  • Chronic obstructive airway disease
  • Not giving consent for study
  • Known lung pathology

结局指标

主要结局

28-day mortality

时间窗: with in 28 days after ICU admission

Outcome(mortality) 28 days after admission

次要结局

  • Duration of hospital stay(with in the discharge from the hopsital)
  • Duration of ICU stay(Duration for which patient stays in ICU after ICU admission)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other
责任方
Principal Investigator
主要研究者

S.K.SHARMA

HOD Medicine

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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