Handling Oxygenation Targets in COVID-19 Patients With Acute Hypoxaemic Respiratory Failure in the Intensive Care Unit: A Randomised Clinical Trial of a Lower Versus a Higher Oxygenation Target
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 726
- 试验地点
- 10
- 主要终点
- Days alive without organ support
研究概览
简要总结
Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory failure at ICU admission.
详细描述
Acutely ill adult COVID-19 patients with hypoxaemic respiratory failure admitted to the intensive care unit (ICU) are at risk of life-threatening hypoxia, and are provided supplementary oxygen. Liberal use of supplementary oxygen may increase the number of serious adverse events including death. However, the use of supplementary oxygen therapy, and the optimal oxygenation target in COVID-19 patients have not yet been studied.
The World Health Organisation (WHO) recommends an oxygen therapy during resuscitation of COVID-19 patients to achieve an SpO2 of 94% or more, and 90% or more when stable (non-pregnant patients). The Surviving Sepsis Campaing (SSC) recommends a conservative oxygenation strategy for COVID-19 patients targeting an SpO2 no higher than 96%. Both are based on a systematic review and metanalysis from 2018, investigating the association with mortality and higher versus lower oxygenation strategies in critically ill patients in general.
COVID-19 patients admitted to the ICU and treated with positive pressure ventilation fulfil the 2012 Berlin criteria for acute respiratory distress syndrome (ARDS). Current practice regarding supplementary oxygen therapy in patients with ARDS follows the regimen used in an randomised clinical trial (RCT) from 2000 comparing lower versus higher tidal volumes; i.e. a partial pressure of arterial oxygen (PaO2) of 55-80 mmHg (7.3-10.7 kPa) or a peripheral oxygen saturation (SpO2) of 88-95%.
Of note, a recent published RCT demonstrated a lowered all-cause mortality when targeting a higher oxygenation target (PaO2: 12-14 kPa [90-105 mmHg]) compared to a lower oxygenation target (PaO2: 7.3-9.3 [55-70 mmHg]) in ARDS patients.
The quality and quantity of the current body of evidence regarding oxygenation targets in ARDS is still low.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acutely admitted to the ICU AND
- •Aged ≥ 18 years AND
- •Receives supplemental oxygen with a flow of at least 10 L per minutes in an open system including high-flow systems OR recieves supplemental oxygen in a closed system including invasive or non-invasive ventilation or continuous positive airway pressure (CPAP)-systems AND
- •Expected to receive supplemental oxygen for at least 24 hours in the ICU AND
- •Having an arterial line for PaO2 monitoring AND
- •Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) in the time leading to or during current hospital admission
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 (< 50 years of age) 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-COVID trial
研究组 & 干预措施
Low oxygenation target
Partial pressure of oxygen in arterial blood (PaO2) 8 kPa (60 mmHg)
干预措施: Low oxygenation target (Drug)
High oxygenation target
Partial pressure of oxygen in arterial blood (PaO2) 12 kPa (90 mmHg)
干预措施: High oxygenation target (Drug)
结局指标
主要结局
Days alive without organ support
时间窗: Within 90 days
Days alive and free from mechanical ventilation, circulatory support and renal replacement therapy
次要结局
- 1-year mortality(1 year)
- Cognitive function 1-year after randomisation as assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score in selected sites(1 year)
- 90-days mortality(90 days)
- Days alive out of the hospital(Within 90 days)
- Number of patients with one or more serious adverse events(Until ICU discharge, maximum 90 days)
- Quality of life assessement using the EuroQoL EQ-5D-5L telephone interview(1 year)
- Carbon monoxide diffusion capacity(1 year)
- A health economic analysis(90 days)
研究者
Bodil Steen Rasmussen
Clinical Professor, MD, PhD
Aalborg University Hospital