Peri-Arrest Ventilation With Positive End-Expiratory-Pressure vs. Zero End-Expiratory-Pressure in Out-of-Hospital-Cardiac-Arrest
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- The return of spontaneous circulation (ROSC)
研究概览
简要总结
Out-of-hospital cardiac arrest (OHCA) remains a major cause of mortality, with low survival probabilities to hospital discharge. Despite the frequent use of airway management and mechanical ventilation during resuscitation, there is limited evidence regarding the optimal ventilation strategy to improve oxygen delivery and patient outcomes. The present study aims to investigate the effects of positive-end-expiratory-pressure (PEEP) set at 5 mbar compared to zero-end-expiratory-pressure (ZEEP) on the return of spontaneous-circulation (ROSC) in adult patients with OHCA.
详细描述
This is a prospective, multicenter, cluster-randomized controlled trial conducted across emergency medical services (EMS) in the regions of Guetersloh, Minden-Luebbecke and Osnabrueck. Adult patients (>= 18 years) with OHCA who are undergoing mechanical ventilation through an airway device will be enrolled. The clusters (regional district) will be randomized into two groups: one group will receive ventilation with PEEP set at 5 mbar (intervention group), while the other group will receive ventilation with ZEEP (control group). The study's primary endpoint is the rate of ROSC. Secondary endpoints include rate of re-arrest, death during pre-hospital care phase, hospital admission during ongoing resuscitation, hospital admission with spontaneous circulation, peripheral oxygen saturation and end tidal CO2 at hospital admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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 >= 18 years
- •non-traumatic OHCA
- •mechanical ventilation via airway device
排除标准
- •Patients < 18 years,
- •traumatic cause of OHCA,
- •no cardiac arrest, withholding of resuscitation (e.g. Do-Not-Resuscitate orders)
结局指标
主要结局
The return of spontaneous circulation (ROSC)
时间窗: During or after resuscitation
The primary outcome is the ROSC, defined according to the Utstein template by the presence of a palpable pulse during or after resuscitation. This will be measured as a binary outcome (palpable pulse, yes or no).
次要结局
- Re-Arrest-Rate(Upon hospital admission)
- Death during pre-hospital care phase(Upon hospital admission)
- Hospital admission during ongoing resuscitation(at hospital admission)
- Hospital admission with spontaneous circulation(at hospital admission)
- SpO2 at hospital admission(at hospital admission)
- FiO2 at hospital admission(at hospital admission)
研究者
Gerrit Jansen
Principal Investigator
Muehlenkreiskliniken, MKK