Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- First Attempt Success Rate Between the Tibial IO, Humeral IO, and Peripheral IV.
研究概览
简要总结
The objective of this study will be to compare humeral and tibial IO needle insertions to peripheral IV access during cardiac arrest.
Hypothesis There is a difference in first attempt success of tibial IOs compared to humeral IOs or peripheral IV among cardiac arrest patients.
This was a randomized trial of adult patients experiencing a medical OOHCA where resuscitation efforts were initiated. Patients were randomized to 1 of 3 routes of vascular access. Prior to every shift, paramedics were distributed a randomly selected note card indicating the prescribed route for vascular access: tibial IO, humeral IO, or peripheral IV.
The selected method applied to the first attempt at vascular access only. Paramedics received intensive training and exposure to all three methods prior to study initiation. The primary outcome was first attempt success defined as secure needle position in the marrow cavity or a peripheral vein with normal fluid flow. Needle dislodgement during resuscitation was counted as a failure to maintain vascular access. In order to detect a statistical difference in the frequency of first attempt success a minimum of 50 patients for each arm of the study were needed.
详细描述
The objective of this study will be to compare humeral and tibial IO needle insertions to peripheral IV access during cardiac arrest.
Hypothesis There is a difference in first attempt success of tibial IOs compared to humeral IOs or peripheral IV among cardiac arrest patients.
Methods This will be a randomized controlled trial conducted within Mecklenburg County by the Mecklenburg County EMS Agency (MEDIC). The study population includes all adult (greater than 18 years of age) cardiac arrest patients of a medical etiology upon whom resuscitative efforts are initiated.
Patient Care Protocols Prehospital protocols for adult cardiac arrest patients within Mecklenburg County state that all first responders follow advanced cardiac life support (ACLS) algorithms during cardiopulmonary resuscitation. Current MEDIC protocols specify that initial vascular access be obtained by paramedics via either tibial or humeral IO needle insertion, followed by peripheral IV for secondary access. This study will randomize initial vascular access to a humeral IO, tibial IO, or peripheral IV.
Once paramedics arrive on-scene, they will take a pack from the ambulance containing all necessary supplies to begin resuscitation. These packs are already present on each ambulance in Mecklenburg County and contain an EZ-IO drill, IO needles, ACLS medications, and KING LTD airway device. For the purposes of this study, peripheral IV start kits will be added to these resuscitation packs at the start of study implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All cardiac arrests of a medical nature in patients greater than or equal to 18 years of age occuring in Mecklenburg county, NC.
排除标准
- •Traumatic cardiac arrests - different prehospital protocols exist for resuscitations involving traumatic arrests (i.e. motor vehicle accidents, motorcycle accidents, falls, and penetrating injuries including stabbings and gunshot wounds).
- •Cardiac arrests due to hemorrhage - for the purposes of this study, such arrests are not considered to be of a "medical etiology" since massive blood loss is the contributing factor and only rapid volume resuscitation is indicated.
- •Cardiac arrests involving children or young adults - any patient less than 18 years of age will be excluded as different prehospital protocols exist for children in cardiac arrest. Age verification will occur upon data collection using patient date of birth when available. Any data collected from a patient found to be less than 18 years of age after resuscitation, will also be excluded from data analysis.
- •Patients with established vascular access prior to cardiac arrest - patients who deteriorate during transport into cardiac arrest but already have a peripheral IV or IO needle established will be excluded from the study. Randomization cannot be applied to these encounters as vascular access has already been selected and documentation by a sole provider is not possible during transport.
- •Patients with a Do Not Resuscitate (DNR) - in some circumstances, cardiopulmonary resuscitation is initially performed on patients until a DNR order is produced. These patients will be excluded from the study as the full protocol cannot be implemented.
结局指标
主要结局
First Attempt Success Rate Between the Tibial IO, Humeral IO, and Peripheral IV.
时间窗: 1 day
This measure will be assessed on the day an individual experiences cardiac arrest and will not be followed upon admission to the emergency department.
次要结局
未报告次要终点