Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest - a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,479
- 试验地点
- 10
- 主要终点
- Sustained return of spontaneous circulation
研究概览
简要总结
The "Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest (IVIO)"-trial is an investigator-initiated, randomized, parallel group, patient and outcome assessor-blinded, superiority trial of intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. The intraosseous group will be further randomized to humeral vs. tibial access. The trial will be conducted in the Central Denmark Region. The primary outcome will be sustained return of spontaneous circulation, and 762 patients will be included. Key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
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
- Double (Participant, 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
- •Out-of-hospital cardiac arrest
- •Age ≥ 18 years
- •Indication for intravenous or intraosseous vascular access during cardiac arrest
排除标准
- •Blunt or penetrating traumatic cardiac arrest
- •Prior enrollment in the trial
- •Intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site
结局指标
主要结局
Sustained return of spontaneous circulation
时间窗: Before or after hospital arrival (up to 2 hours after the cardiac arrest)
Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes
次要结局
- Favorable neurological outcome(30 days after the cardiac arrest)
- Survival(30 days after the cardiac arrest)
研究者
Lars Wiuff Andersen
Associate Professor
Aarhus University Hospital