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临床试验/ISRCTN99817649
ISRCTN99817649已完成不适用

A trial of Helium-Oxygen mixtures in the immediate Post Extubation period in adult intensive care, using novel Decision-Theoretic Statistical Methodology

Cambridge University Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 100 人开始时间: 2006年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100

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

性别
All

入选标准

  • Amended as of 24/03/2009:
  • 1. Cuff leak less than 140 ml after 48 hours mechanical ventilation
  • 2. Suction more often than 2-hourly in the 4 - 6 hours prior to extubation
  • 3. Failure of earlier spontaneous breathing trial
  • 4. Intubated for airway obstruction
  • 5. Hypercapnia greater than 6 kPa (45 mmHg) on last gas prior to extubation
  • 6. Glasgow Coma Score less than 8 (Verbal Score is 1)
  • 7. Cough peak flow less than 70 l/min
  • 8. Mechanical ventilation greater than 48 hours and Rapid Shallow Breathing Index greater than 57 and a positive fluid balance over the previous 24 hours
  • 9. Mechanical ventilation greater than 48 hours and a positive fluid balance of greater than 1 litre over previous 24 hours
  • Initial information at time of registration:
  • 1. Intubated for airway obstruction
  • 2. Glasgow Coma Score of less than eight at extubation
  • 3. Failing a rapid wean protocol
  • 4. Significant bronchorrhoea
  • 5. Cuff Leak of less than 140 ml
  • 6. Cough peak flow less than 60 ml/min

排除标准

  • Amended as of 24/03/2009:
  • 1. Recent or current diagnosis of pneumothorax, surgical emphysema, or fractured ribs
  • 2. Patients in whom there is no intention to re-ventilate upon tracheal extubation i.e. terminal extubation
  • 3. Patients who are extubated accidentally
  • 4. Patients with a tracheostomy
  • 5. Patients who have been admitted to intensive care electively following surgery
  • 6. Patients who use non-invasive ventilation (NIV) at home
  • 7. Patients in whom there is clinical doubt from the research team concerning the clinical decision to extubate the patient, where recourse to the critical care consultant on duty is not available
  • 8. Next of kin refuse assent
  • 9. Informed consent is refused by the patient or their legally appointed representative at any stage during or after data collection
  • Initial information at time of registration:
  • 1. Recent or current diagnosis of pneumothorax, surgical emphysema, or fractured ribs
  • 2. Patients in whom there is no intention to re-ventilate upon tracheal extubation i.e. terminal extubation
  • 3. Patients who are extubated accidentally
  • 4. Patients with a tracheostomy
  • 5. Patients who have been admitted to Intensive Care following elective surgery
  • 6. Next of kin refuse assent
  • 7. Informed consent is refused by the patient or their legally appointed representative
  • at any stage during or after data collection

研究者

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