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临床试验/CTRI/2019/05/019050
CTRI/2019/05/019050已完成不适用

Early use of Non Invasive Positive Pressure Ventilation in Acute Hypoxemic Respiratory Failure in Acute Pancreatitis: A Randomised Controlled Trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2019年5月20日最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
1. Need for invasive mechanical ventilation
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The role of non invasive ventilation(NIV) in acute hypoxemic respiratory failure remains unclear. This trial’s objectives are:

  1. to compare early NIV with conventional oxygen therapy for grade II/III acute hypoxemic respiratory failure in patients with acute pancreatitis in terms of need for invasive ventilation.

  2. To study the frequency, causes amd imapct of respiartory failure on outcome in patients with acute pancreatitis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)（—）
性别
All

入选标准

  • •1.Acute pancreatitis as defined by revised Atlanta classification.1
  • •Hospitalisation within 14 days of date of onset of pain.
  • •3.Grade II/III respiratory failure as defined by modified Marshall’s criteria.

排除标准

  • •1.Age < 18 years or > 70 years 2.Pregnancy 3.Failure to give consent 4.Undrained large pleural effusion 5.Previous mechanical ventilation in last 7 days 6.Contraindications to NIV use: a.Glasgow coma scale <13/
  • •b.Airway/facial injury.
  • •c.Hypotension requiring inotropes.
  • •d.Intractable vomiting.
  • •e.Active gastrointestinal bleeding.
  • •f.Untreated paralytic ileus.
  • •g.Untreated pneumothorax.
  • •h.Acute myocardial infarction/arythmmia/congestive heart failure.
  • •7.Underlying chronic obstructive airway disease(COPD).

结局指标

主要结局

1. Need for invasive mechanical ventilation

时间窗: within 30 days

2. Hospital acquired pneumonia

时间窗: within 30 days

次要结局

  • 1. mortality within 30 days(2. Duration of ICU stay)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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