Pragmatic Trial of Airway Management in Out-of-Hospital Cardiac Arrest

院外心脏骤停气道管理的实用试验

基本信息

批准号：
9116937
负责人：
Henry E. Wang
金额：
$ 68.95万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-19 至 2019-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9116937
关键词：
Adult Adverse event Affect American Award Blood Circulation Blood flow Bradycardia Brain Breathing Cardiopulmonary Arrest Cardiopulmonary Resuscitation Caring Chest Cities Clinical Clinical Trials Critical Care Critical Illness Data Collection Development Disclosure Distal Emergency Care Enrollment Funding Gel Health Heart Heart Arrest Hospitals Hour Hyperventilation Hypoxia Individual Institutional Review Boards International Interruption Intervention Trial Intratracheal Intubation Intubation Ischemia Laryngeal Masks Larynx Lead Life Lung National Heart, Lung, and Blood Institute North America Oral cavity Organ Outcome Oxygen Paramedical Personnel Patient-Focused Outcomes Pennsylvania Performance Persons Pharyngeal structure Pragmatic clinical trial Procedures Process Provider Public Health Qualifying Randomized Randomized Clinical Trials Research Infrastructure Resources Resuscitation Techniques Testing Trachea Training Tube United States United States Food and Drug Administration base capsule clinical practice cohort community consultation cost experience heart function improved outcome injured novel patient oriented pragmatic trial prospective protocol development response secondary outcome trial comparing trial design

项目摘要

DESCRIPTION (provided by applicant): This proposal is submitted in response to RFA-HL-14-019 "Low-Cost, Pragmatic, Patient-Centered Randomized Controlled Intervention Trials." Cardiopulmonary arrest is the critical illness resulting from sudden cessation of heart function and circulatory blood flow. Sudden out-of-hospital cardiopulmonary arrest (OHCA) is a major public health problem, affecting over 300,000 persons in the United States each year, with only 8% surviving. Successful cardiac arrest resuscitation requires delivery of life-saving oxygen to the heart and brain. Airway management is the process of opening the mouth and throat to deliver oxygen to the lungs for circulation to the vital organs. Paramedics commonly accomplish airway management using endotracheal intubation (ETI), the insertion of a plastic breathing tube through the mouth and into the trachea. However, paramedic ETI is risky and resource intensive. Supraglottic airways (SGA - such as the King Laryngeal Tube, Combitube, and Laryngeal Mask Airway) are simpler alternatives but have unproven outcomes. The best strategy for OHCA airway management remains unknown. We propose a multicenter pragmatic clinical trial comparing 1) ETI with 2) SGA airway management in paramedic resuscitation of adult OHCA. We will carry out the trial using the massive existing infrastructure of the NHLBI-funded Resuscitation Outcomes Consortium (ROC), a highly successful 10-city collaborative specializing in OHCA trials. The aims of the study are: � Specific Aim I: Prepare the Resuscitation Outcomes Consortium for execution of a pragmatic trial of airway management strategies in out-of-hospital cardiopulmonary arrest. Per the RFA, we will complete preparatory tasks necessary to carry out the trial. � Specific Aim II: Determine the effect of paramedic airway management strategy (SGA vs. ETI) upon outcomes after adult OHCA. We will test the hypothesis that rates of OHCA 72-hour survival are higher with SGA- than ETI-based airway management strategies. This landmark trial will answer one of the most urgent and controversial clinical questions in OHCA care; "What is the best way to manage the airway?" The study findings will have immediate and lasting impact upon paramedic clinical practices internationally. ROC is the only network in the world poised to efficiently carry out a trial of this design and magnitude. The study will be spearheaded by the world's leading experts in out-of- hospital airway management and cardiopulmonary arrest.

描述（由申请人提供）：本提案是针对 RFA-HL-14-019“低成本、务实、以患者为中心的随机对照干预试验”而提交的。心肺骤停是因心脏功能突然停止而导致的危重疾病。院外突发心肺骤停 (OHCA) 是一个重大的公共卫生问题，影响超过美国每年有 30 万人，其中只有 8% 存活下来。成功的心脏骤停复苏需要向心脏和大脑输送救生氧气。气道管理是张开嘴和喉咙向肺部输送氧气的过程。护理人员通常使用气管插管 (ETI) 来完成气道管理，即通过口腔将塑料呼吸管插入气管。但是，护理人员 ETI 存在风险。声门上气道（SGA - 例如 King 喉管、Combitube 和喉罩气道）是更简单的替代方案，但 OHCA 气道管理的最佳策略仍然未知。 ) ETI 与 2) SGA 成人 OHCA 护理人员复苏中的气道管理我们将利用 NHLBI 资助的现有大型基础设施进行试验。复苏结果联盟 (ROC) 是一个非常成功的 10 个城市合作机构，专门从事 OHCA 试验。该研究的目的是：具体目标 I：准备复苏结果联盟，以执行气道管理策略的务实试验。 - 医院心肺骤停。根据 RFA，我们将完成进行试验所需的准备工作。具体目标 II：确定护理人员的效果。基于成人 OHCA 后的气道管理策略（SGA 与 ETI）我们将检验以下假设：基于 SGA 的 OHCA 72 小时生存率高于基于 ETI 的气道管理策略这一具有里程碑意义的试验将回答最重要的问题之一。 OHCA 护理中紧迫且有争议的临床问题；“管理气道的最佳方法是什么？” ROC 是世界上唯一准备有效实施的网络。这项设计和规模的试验将由院外气道管理和心肺骤停领域的世界领先专家牵头。