rEduction of oXygen After Cardiac arresT (EXACT): a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- oxygen saturation ≥90%
研究概览
简要总结
This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen delivery in adult patients who have been resuscitated from OHCA.
详细描述
This Phase 2 study aims to test whether paramedic titration of oxygen is feasible and results in an equivalent number of patients arriving at the ED with a safe oxygen level compared with the current approach of 100% oxygen.
Hypothesis: There is no difference in the proportion of OHCA patients who arrive at the emergency department with oxygen saturation greater than or equal to 90% whether they received an inspired oxygen fraction of 100% achieved by a flow rate of 10 litres per minute compared to a titrated oxygen fraction achieved by a flow rate of 2 litres per minute.
This is a Phase 2, multi-centre, prospective, randomised study to be conducted in Melbourne and Adelaide.
During cardiac arrest, the patient will receive the current standard of care with oxygen delivery (≥10L/min) by ETT/ SGA connected to bag/valve/ oxygen reservoir.
If ROSC is achieved, all the standard post resuscitation treatments will be given as per current ambulance Clinical Practice Guidelines, except for the amount of oxygen delivered.
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
- None
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)
- •Out-of-hospital cardiac arrest of presumed cardiac cause
- •Initial cardiac rhythm ventricular fibrillation/ ventricular tachycardia ("shockable")
- •Unconscious (Glasgow Coma Scale <9)
- •In cardiac arrest on ambulance arrival
- •Sustained return of spontaneous circulation (>2 minutes)
- •Pulse oximeter trace with oxygen saturation measured at ≥95% on bag/ reservoir with oxygen set at ≥10L/min
- •Patient is spontaneous breathing or ventilated using bag/valve/oxygen reservoir via endotracheal tube or SGA (i.e. laryngeal mask airway)
排除标准
- •Female who is known or suspected to be pregnant
- •Dependant on others for activities of daily living (i.e. facilitated care or nursing home residents)
- •"Not for Resuscitation" order
- •EMS witnessed arrests
研究组 & 干预措施
Oxygen reduction
post-ROSC oxygen reduced to 2L per minute then delivered to maintain oxygen saturation 90-94% to hospital
干预措施: Oxygen (Drug)
Standard Care
post-ROSC oxygen maintained ≥10L per minute to hospital
干预措施: Oxygen (Drug)
结局指标
主要结局
oxygen saturation ≥90%
时间窗: baseline
Oxygen saturation measured on arrival at hospital by paramedics
次要结局
未报告次要终点
研究者
Professor Stephen Bernard
Professor
Monash University