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Basic Life Support Termination of Resuscitation Implementation Study

2015年11月16日 更新者:Dr. Laurie Morrison、Sunnybrook Health Sciences Centre

Basic Life Support Termination of Resuscitation in the Prehospital Environment for Primary Care Paramedics - A Prospective Observational Study of the Implementation of a Clinical Prediction Rule

In Ontario, most people who experience a cardiac arrest at home (when their heart stops beating) only receive basic life support from Primary Care Paramedics (PCPs) and all are transported to the hospital. Most are pronounced dead by the emergency physician as the mean survival rate for these patients is 5%. Allowing Primary Care Paramedics to use a termination of resuscitation guideline would identify futile cases for which further resuscitation is unwarranted and decrease the number of patients being transported to the emergency department (ED) for pronouncement.

There are numerous advantages to this strategy; first, it may improve the efficiency of the ED because cardiac arrest patients require immediate attention that is diverted from patients who have a better chance at survival. Second, the risk of injury and the monetary costs for the paramedic and the public would be minimized with fewer "light and sirens" transports which are known to be hazardous to motorists, pedestrians, and Emergency Medical Services (EMS) personnel.

For each cardiac arrest, PCPs will respond to the call as usual and implement standard basic life support cardiac arrest protocols. Patients are then categorized according to the termination of resuscitation recommendations:

  1. no return of spontaneous circulation is achieved (no heartbeat);
  2. no shock was given prior to transport; and
  3. the arrest (when the heart stops beating) was not witnessed by EMS personnel.

If all of these criteria are true, the PCP will contact the hospital and the decision by the emergency physician will then be made to stop life saving measures (terminate resuscitation) in the home or continue with life support and transport the patient to the local emergency department.

This study aims to document the usefulness of the termination of the resuscitation guideline in decreasing the rate of transport of out-of-hospital cardiac arrest patients to the ED. Secondary aims of this implementation study will be to describe the rates of erroneous application of the guideline. The comfort of use of the rule among paramedics and base hospital emergency physicians will be described.

研究概览

地位

完全的

条件

详细说明

In Ontario, most victims of out-of-hospital cardiac arrest (OHCA) do not receive Advanced Cardiac Life Support (ACLS); rather, they receive only Basic Life Support (BLS) from Primary Care Paramedics (PCPs), where the survival rate is approximately 5%. Every one of these patients is transported to the Emergency Department (ED), where the vast majority are pronounced dead. Conversely, patients who do not respond to ACLS by Advanced Care Paramedics (ACPs) are pronounced dead in the field via patching to the Base Hospital Physician (BHP). Implementation of a termination of resuscitation (TOR) guideline for the PCP's use would decrease the number of non-viable patients transported to the ED.

A reduction of unsuccessfully resuscitated cardiac arrest patients transported to the ED would have numerous advantages. First, it may improve the efficiency of the ED health care system because cardiac arrest patients in the ED require immediate attention that is diverted from potentially more salvageable patients. Second, the risk of injury and the monetary costs for the paramedic and the public would be minimized with fewer "light and sirens" transports which are known to be hazardous to motorists, pedestrians, and EMS personnel. Additionally, it is less expensive to pronounce non-viable patients in the field. And, finally termination of resuscitative efforts in the field permits the paramedic to turn his attention and skill set to supporting the family through the initial stages of grief.

The most recent American Heart Association (AHA) emergency cardiac care guidelines suggest that there is a need to develop TOR protocols for PCPs in situations where ACLS care is not rapidly available, and call for more scientific evidence to support the implementation of such guidelines.

We derived and prospectively validated a clinical prediction rule to guide PCP termination of resuscitation in out of hospital cardiac arrest.

The TOR implementation study aims to document the usefulness of the TOR guideline, as specified by a newly developed medical directive, in decreasing the rate of transport of OHCA patients to the ED. Secondary aims of this implementation study will be to describe the rates of erroneous application of the guideline. The comfort of use of the rule among paramedics and base hospital emergency physicians will be described.

This will be a multi-centre prospective implementation study involving a combination of urban and rural regional EMS systems across Ontario. Included will be consecutive patients who suffer from non-traumatic cardiac arrest (i.e. of presumed cardiac etiology). Identical to the derivation and validation phase, patients will be excluded from the study if: their arrest is due to trauma, drowning or drug overdose; they receive any prehospital ACLS care; they possess a documented "Do Not Resuscitate" directive; or they are less than 18 years of age.

Cases that meet inclusion criteria will be enrolled consecutively. For each cardiac arrest, paramedics will respond to the call as usual and initiate resuscitation attempts. Patients suffering from cardiac arrest that (1) was not witnessed by EMS personnel; (2) had no shocks delivered by anyone; and (3) have had no return of spontaneous carotid or femoral pulse meet the criteria for TOR. In these circumstances PCPs will patch to the local BHP using the standard patching process. The BHP will then direct the paramedic to either continue resuscitation and transport, or terminate resuscitation in the field based on the TOR guideline and their clinical judgment of each individual call. In the case of failure of the paramedic to reach the BHP, the paramedic is directed to continue resuscitation and transport as per normal procedures, regardless of what the TOR guideline recommends. Data for each case will be requested from both the paramedic and the emergency physician using a uniform data collection sheet and the standardized Ontario Ambulance Call Report (ACR).

The rate of patient transport to the ED will be calculated. The obtained rate of transport will be compared to the theoretical rate obtained in the validation study, 37.4% using a one sample test, two sided, test of proportions, in order to evaluate the utility of the rule to decrease transport rates. Rates of erroneous application of the rule by both paramedics and emergency physicians will be calculated by identifying and tabulating the various reason for non-compliance. Occurrence of adverse patient outcomes, such as ROSC after TOR will be closely monitored.

研究类型

观察性的

注册 (实际的)

350

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Barrie、Ontario、加拿大、L4N 1K4
        • Royal Victoria Hospital
      • Cornwall、Ontario、加拿大、K6H 1Z6
        • Cornwall Community Hospital
      • Hamilton、Ontario、加拿大、L8V 1C3
        • Hamilton Health Sciences
      • Owen Sound、Ontario、加拿大、N4K 6M9
        • Grey Bruce Huron
      • Peterborough、Ontario、加拿大、K9J 7C6
        • Peterborough Regional Health Center
      • Sault Ste Marie、Ontario、加拿大、P6A 2C4
        • Sault Area Hospital
      • Timmins、Ontario、加拿大、P4N 8P2
        • Timmins and District Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

This is a multi centre prospective observational study of the implementatiaon of a Basic Life Support Termination of Resuscitation(BLS TOR)guideline.The study will accrue all out of hospital cardiac arrest cases from 9 regions across the province of Ontario(Cornwall, Hamilton,Peel, Peterborough, Grey Bruce Huron, Timmins, Sault Ste Marie, Simcoe/Muskoka, Cambridge). There are 22 participating EMS systems over the 9 regions.

描述

Inclusion Criteria:

  • Age > 18
  • No advanced cardiac life support procedures (ACLS) were available during the call
  • The cardiac arrest is of presumed cardiac cause only

Exclusion Criteria:

  • Age < 18
  • The patient possesses a documented do-not-resuscitate (DNR) order
  • The cardiac arrest is due to non cardiac causes such as trauma, drowning or drug overdose
  • Patient receives any prehospital ACLS care

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Laurie J Morrison, MD、Rescu, St. Michael's Hospital Toronto
  • 首席研究员:Richard P Verbeek, MD、Division of Emergency Medicine, Department of Medicine, University of Toronto and Sunnybrook Osler Center for Prehospital Care
  • 首席研究员:Don Eby, MD、Grey Bruce Huron Paramedic Base Hospital Program, Grey Bruce Health Services, Owen Sound Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年1月1日

初级完成 (实际的)

2010年12月1日

研究完成 (实际的)

2012年6月1日

研究注册日期

首次提交

2006年8月29日

首先提交符合 QC 标准的

2006年8月29日

首次发布 (估计)

2006年8月31日

研究记录更新

最后更新发布 (估计)

2015年11月17日

上次提交的符合 QC 标准的更新

2015年11月16日

最后验证

2015年11月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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