EUCTR2017-000632-34-DK进行中（未招募）1 期
Handling oxygenation targets in adults with acute hypoxaemic respiratory failure in the intensive care unit: A randomised clinical trial of a lower versus a higher oxygenation targetAddendum: Trial extension including only patients with SARS-CoV-2 positive tests (COVID-19) - Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU)
Department of Anaesthesia and Intensive Care Medicine, Aalborg University Hospital0 个研究点目标入组 3,708 人开始时间: 2017年2月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,708
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
- •- Acutely admitted to the intensive care unit AND
- •- Aged = 18 years AND
- •- Receive supplemental oxygen with a flow of at least 10 L per minute in an open system or at least an fraction of inspired oxygen of 0.50 in a closed system, including invasive ventilation, non-invasive ventilation or continuous positive airway pressure AND
- •- Are expected to receive oxygen administration for at least 24 hours in the ICU AND
- •- Have an arterial line in place
- •- Acutely admitted to the intensive care unit AND
- •- Aged = 18 years AND
- •- Supplemental oxygen with a flow of at least 10 L oxygen per minutes in an open system including high-flow systems OR invasive or non-invasive mechanical ventilation/CPAP systems independent of the FiO2 AND
- •- Are expected to receive oxygen administration for at least 24 hours in the ICU AND
- •- Have an arterial line in place
- •- Confirmed SARS-CoV-2 infection in the time leading to or during current hospital admission
- •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 1554
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2154
排除标准
- •- Cannot be randomised within twelve hours after present ICU admission
- •- Chronic mechanical ventilation for any reason
- •- Use of home oxygen
- •- Previous treatment with bleomycin
- •- Organ transplant during current hospital admission
- •- Withdrawal from active therapy or brain death deemed imminent
- •- Fertile woman with positive urine human gonadotropin (hCG) or
- •plasma-hCG
- •- Carbon monoxide poisoning
- •- Cyanide poisoning
- •- Methaemoglobinaemia
- •- Paraquat poisoning
- •- Any condition expected to involve the use of hyperbaric oxygen (HBO)
- •- Sickle cell disease
- •- Consent not obtainable according to national regulations
- •- Previously randomised into the HOT-ICU trial
- •Addendum: Identical criteria.
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