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临床试验/NCT01372748
NCT01372748已完成4 期

Trial Of Continuous Compressions Versus Standard CPR In Patients With Out-Of-Hospital Cardiac Arrest

University of Washington7 个研究点 分布在 2 个国家目标入组 23,711 人开始时间: 2011年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
23,711
试验地点
7
主要终点
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge

研究概览

简要总结

The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA). The primary null hypothesis will be that the rate of survival to hospital discharge is not affected by use of continuous compressions with passive or positive pressure ventilation (intervention group) versus CPR with compressions interrupted for ventilation at a ratio of 30:2 (control group).

详细描述

The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA). For this study, CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation followed by rhythm analysis or until restoration of spontaneous circulation (ROSC), whichever occurs first. ICC consists of series of three cycles of standard CPR each cycle comprised of chest compressions with interposed ventilations at a compression:ventilation ratio of 30:2 (per AHA guidelines) followed by rhythm analysis or until ROSC, whichever occurs first. In either patient group, the duration of manual CPR before the first rhythm analysis will be 30 seconds or 120 seconds. This treatment period will be followed by two cycles of compressions then rhythm analysis (i.e. each of approximately 2 minutes duration) in either group. Other aims of the trial are to compare survival to discharge among patients grouped by first-recorded rhythm or other a priori subgroups, as well as to compare neurological status at discharge, mechanistic outcomes or adverse events between control and intervention groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • •Age 18 years or more (or local age of consent);
  • •Initial fire/Emergency Medical Services (EMS) chest compressions provided by Resuscitation Outcomes Consortium (ROC) study participating agency dispatched to the scene;
  • •Lack of the

排除标准

  • •Exclusion Criteria:
  • •EMS witnessed arrest;
  • •Written do not attempt resuscitation (DNAR) orders;
  • •Obvious primary asphyxia or respiratory cause of arrest (drowning, strangulation, hanging)
  • •Advanced airway placed prior to ROC EMS arrival, or pre-existing tracheostomy
  • •Traumatic cause (blunt, penetrating, burn) of arrest;
  • •Known prisoners;
  • •Known pregnancy;
  • •Uncontrolled bleeding or exsanguination
  • •Mechanical compression device used during study-assigned compression cycles

研究组 & 干预措施

Standard CPR

Active Comparator

American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations

干预措施: Standard CPR (Other)

Continuous chest compressions

Experimental

Continuous compression CPR

干预措施: Continuous chest compressions (Other)

结局指标

主要结局

Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge

时间窗: Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.

Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.

次要结局

  • Percentage of Participants Scoring at or Below a 3 on the MRS Scale(Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susanne May

Principal Investigator

University of Washington

研究点 (7)

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