Reduction of Oxygen After Cardiac Arrest (EXACT): The EXACT Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 428
- 试验地点
- 42
- 主要终点
- Survival to hospital discharge
研究概览
简要总结
The Reduction of oxygen after cardiac arrest (EXACT) is a multi-centre, randomised, controlled trial (RCT) to determine whether reducing oxygen administration to target an oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful resuscitation from OHCA improves outcome at hospital discharge.
详细描述
Currently out-of-hospital cardiac arrest (OHCA) patients who achieve ROSC are routinely ventilated with the highest fraction of inspired oxygen (FiO2) possible (i.e. FiO2 1.0 or 100% oxygen) until admission to an intensive care unit (ICU) - usually a period of 2 to 6 hours post-ROSC.
Post-ROSC oxygen therapy begins in the field by emergency medical services (EMS). EMS typically deliver a high flow of oxygen at rate of >10L/min (~100% oxygen), and use a pulse oximeter to monitor oxygen levels (SpO2). Normal SpO2 levels are considered to be 94% to 100%. The delivery of 100% oxygen is then usually continued throughout a patient's stay in the emergency department (ED) and during any diagnostic testing (e.g. computed tomography scans and cardiac angiography). During this time, oxygen is delivered to patients who remain unconscious via a mechanical ventilator, with levels continuously monitored by pulse oximetry and periodically by a blood test called an arterial blood gas (ABG). The ABG measurements include the oxygen pressure in the blood (PaO2) in mmHg. Once a patient is admitted to the ICU, the PaO2 is assessed and the oxygen fraction is typically reduced and then titrated (reduced or increased) on the ventilator to achieve a normal level of PaO2 ("normoxia") of between 80-100mmHg.
The administration of 100% oxygen for the first hours after resuscitation is based largely on convention and not on any supportive clinical data. It has been thought that maximizing oxygen delivery for several hours might be beneficial in a patient who has suffered profound deprivation of oxygen supply ("hypoxia") during a cardiac arrest. In addition, if a lower fraction of inspired oxygen is delivered, there is a perceived risk that the patient might become hypoxic (i.e. SpO2 <90% or PaO2 <80mmHg). Until recently, there has been no particular reason to recommend a decrease in oxygen delivery to the post-arrest patient prior to admission to ICU.
However, recent systematic reviews of compelling experimental data and supportive human observational studies indicate that the administration of 100% oxygen can create "hyperoxic" levels in the early post arrest period which may lead to additional neurological injury, and thus result in worse clinical outcome. No randomised control trials have yet tested titrating oxygen administration to lower but normal levels (i.e. "normoxia").
EXACT is a Phase 3 multi-centre, randomised, controlled trial (RCT) aiming to determine whether reducing oxygen administration to target an oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful resuscitation from OHCA improves outcome at hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, 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
- •Adults (age 18 years or older)
- •Out-of-hospital cardiac arrest of presumed cardiac cause
- •All cardiac arrest rhythms
- •Unconscious (Glasgow Coma Scale <9)
- •Return of spontaneous circulation
- •Pulse oximeter measures oxygen saturation at ≥95% with oxygen flow set at >10L/min or FiO2 at 100%
- •Patient has an endotracheal tube (ETT) or supraglottic airway (SGA) (e.g. laryngeal mask airway -LMA) and is spontaneously breathing or ventilated
- •Transport is planned to a participating hospital
排除标准
- •Female who is known or suspected to be pregnant
- •Dependent on others for activities of daily living (i.e. facilitated care or nursing home residents)
- •"Not for Resuscitation" order or Advanced Care Directives in place
- •Pre-existing oxygen therapy (i.e. for COPD)
- •Cardiac arrest due to drowning, trauma or hanging
结局指标
主要结局
Survival to hospital discharge
时间窗: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Survival to hospital discharge
次要结局
- Survival at 12 months(12 months)
- Quality of Life EQ-5D-3L(12 months)
- Neurological Function(12 months)
- Neurological outcome(At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks)
- Incidence of hypoxia (SpO2<90%)(Before ICU admission, an expected average of 4-6 hours)
- Survival to intensive care unit discharge(Intensive care discharge, an expected average of 7 days)
- Recurrent cardiac arrest(Before ICU admission, an expected average of 4-6 hours)
- Length of ICU stay(Intensive care discharge, an expected average of 7 days)
- Length of hospital stay(At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks)
- Quality of Life SF-12(12 months)
- Myocardial Injury(First 24 hours of hospital admission)
- Cause of death during hospital stay(At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks)
- Degree of recovery (GOS-E)(12 months)
研究者
Professor Stephen Bernard
Professor
Monash University