EUCTR2008-006173-33-BE进行中（未招募）1 期
An international Phase III randomised trial comparing in severe Exacerbations of Chronic obstructive pulmonary disease the efficacy of Helium/Oxygen versus Air/Oxygen administered during spontaneous breathing and intermittent non-invasive ventilation. The E.C.H.O.ICU trial. - E.C.H.O. ICU Trial
Air Liquide Santé International0 个研究点目标入组 670 人开始时间: 2009年9月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 670
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Male or female patient, aged = 35 years,
- •2)Patient with known or suspected COPD,
- •3)Patient presenting current exacerbation of COPD with hypercapnic acute respiratory failure,
- •4)Patient presenting the following criteria for starting Non-Invasive
- •Ventilation (NIV) sessions:
- •4.a) PaCO2 = 45 mmHg (6.0 kPa), AND arterial pH = 7.35,
- •And at least 1 of the following:
- •4.b) Respiration rate = 25 breaths per minute,
- •4.c) PaO2 = 50 mmHg (6.7 kPa) or SaO2 = 90% or SpO2 = 90%,
- •5)Patient admitted in an ICU,
- •6)Written informed consent signed and dated by the patient or next of kin after full explanation of the study by the investigator prior to participation,
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •7) Patient previously randomised in the study,
- •8) Patient admitted in the ICU for more than 24 hours and/or having received Non-Invasive Ventilation (NIV) in ICU for more than 6 hours (in total) for the current exacerbation of COPD,
- •9) Patient with tracheostomy,
- •10) Patient who had lung transplant,
- •11) Patient having a contraindication to NIV:
- •11.a) Respiratory arrest, severe acute respiratory failure with high probability of imminent intubation,
- •11.b) Sustained haemodynamic instability (hypotension with systolic blood pressure < 90 mmHg despite volume loading and/or administration of vasopressor treatment),
- •11.c) Coma, impaired consciousness, uncooperative patient, neurologic instability not due to acute hypercapnia (e.g., stroke, substance abuse or withdrawal, …),
- •11.d) Shock or multiple organ failure syndrome,
- •11.e) Severe ventricular rhythm disorders,
- •11.f) Uncontrollable vomiting,
- •11.g) Recent facial or gastro-oesophageal surgery, severe craniofacial trauma,
- •12) Patient requiring oxygen flow rate > 6 L/min or FIO2 > 0.50,
- •13) Patient with acute respiratory failure believed to be attributable to a current significant chronic disease other than COPD (asthma, significant bronchiectasis, cystic fibrosis, sarcoidosis, lung fibrosis, kyphoskoliosis, neuromuscular disease, …), or to severe pulmonary embolism, extensive pneumonia or pneumothorax (either currently documented and not drained at selection or recent episode < 1 month),
- •14) Patient with severe concomitant chronic systemic disease with a limited probability of survival (< 6 months),
- •15) Pregnant or lactating woman,
- •16) Patient with known or suspected allergy to facemask compounds,
- •17) Patient who has received another investigational drug within 30 days prior to selection.
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