Ignite Creation Date:
2024-05-05 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00683683
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2008-05-15
Brief Title:
The Strategies for Post Arrest Resuscitation and Care Network
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
The Strategies for Post Arrest Resuscitation and Care Network
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARC
Brief Summary:
Background One of the 2010 Impact Goals of the Emergency Cardiac Care ECC Committee of the American Heart Association is to double survival from cardiac arrest Currently approximately 60 of adults and 50 of paediatric patients that regain spontaneous circulation following cardiac arrest die before leaving the hospital A key piece of the chain of survival is this fifth link the care of patients post-arrest Although there are several modalities recommended for post arrest care therapeutic hypothermia is the only in-hospital therapy that has been demonstrated in randomized clinical trials to improve patient outcome after cardiac arrest Despite the strong evidence for its efficacy and the apparent simplicity of this intervention recent surveys show that hypothermia is delivered inconsistently incompletely and with undue delay in hospitals receiving resuscitated patients only 26 of physicians and 26 of hospitals regularly institute a hypothermia protocol
Primary Objective To design and apply a knowledge translation program for the 2005 AHA guideline on hypothermia post cardiac arrest and enable effective implementation of hypothermia in 100 of eligible OHCA patients The integration of two robust data collection systems which include both pre-hospital and in-hospital indicators will give complete process of care and clinical outcome information for all cardiac arrest patients
Primary Endpoint the proportion of eligible out of hospital cardiac arrest patients cooled to 32-34C within 6 hours of ED arrival
Study Design This project will be implemented through an established research collaborative of 43 hospitals in southern Ontario currently participating in the Toronto site of the Resuscitation Outcomes Consortium A stepped wedge study design will be employed whereby the intervention will be rolled-out sequentially to the participating hospitals over a number of time periods as sites reach pre-defined benchmarks The multifaceted KT strategy will include 1 local multidisciplinary champions in ED ICU and Cardiology 2 A simple protocol for application of hypothermia tailored to local needs and policy 3 Identification of perceived and actual barriers to knowledge use 4 Development of an implementation tool kit and 5 Providing timely feedback on benchmarks for hypothermia and outcomes
Primary Objective To design and apply a knowledge translation program for the 2005 AHA guideline on hypothermia post cardiac arrest and enable effective implementation of hypothermia in 100 of eligible OHCA patients The integration of two robust data collection systems which include both pre-hospital and in-hospital indicators will give complete process of care and clinical outcome information for all cardiac arrest patients
Primary Endpoint the proportion of eligible out of hospital cardiac arrest patients cooled to 32-34C within 6 hours of ED arrival
Study Design This project will be implemented through an established research collaborative of 43 hospitals in southern Ontario currently participating in the Toronto site of the Resuscitation Outcomes Consortium A stepped wedge study design will be employed whereby the intervention will be rolled-out sequentially to the participating hospitals over a number of time periods as sites reach pre-defined benchmarks The multifaceted KT strategy will include 1 local multidisciplinary champions in ED ICU and Cardiology 2 A simple protocol for application of hypothermia tailored to local needs and policy 3 Identification of perceived and actual barriers to knowledge use 4 Development of an implementation tool kit and 5 Providing timely feedback on benchmarks for hypothermia and outcomes
Detailed Description:
Substantial resources are spent in providing emergency medical services to victims of out-of-hospital cardiac arrest The science of pre-hospital medicine has advanced considerably over the past decade Specifically EMS services and medical directors have developed carefully designed protocols intensive training and very substantial resources in attempting to improve the immediate outcomes in patients with out-of-hospital cardiac arrest It is anticipated that approximately 200-400 patients per year in the Greater Toronto Area are successfully resuscitated by Emergency Medical Services personnel and be admitted to hospital with intact circulatory function
Unfortunately many of these patients will then die following hospital admission from one of a variety of complications of the initial cardiac arrest The in-hospital attrition rate is approximately 50 and is the result of short and longer-term organ damage suffered during the circulatory arrest as well as in-hospital complications including pulmonary neurological septic and multi-organ dysfunction related complications
Although guidelines for specific aspects of intensive care therapy of critically ill patients have been developed for example ventilation guidelines sepsis prevention and therapy guidelines treatment of metabolic disorders etc practical guidelines which are specifically aimed at the investigation and treatment of patients resuscitated from out-of-hospital cardiac arrest do not currently exist
Preliminary studies in press suggest that a program of comprehensive and consistent adherence to a specific set of standard procedures in intensive care units can lead to a substantial improvement in the survival of patients resuscitated from cardiac arrest One recent example is a study from Oslo Norway which showed substantial improvements in survival to discharge following out-of-hospital cardiac arrest after a set of informal guidelines were adopted by participating intensive care units
There are multiple reasons for the lack of clearly articulated guidelines and protocols for the investigation and treatment of patients resuscitated following cardiac arrest however the two most obvious are lack of understanding of the current recommended best practices and practical impediments to their efficient implementation in all units
The Resuscitation Outcomes Consortium ROC an NIH funded multi-centre effort seeks to randomize over 10000 patients in selected North American sites to study specific interventions designed to improve long term survival in patients with out-of-hospital cardiac arrest As part of this consortium intensive care units in the ROC hospitals are being invited to join a new best practice initiative entitled Strategies for Post Arrest Care in the ICU SPARC
Working with more than 50 hospitals across Ontario the objectives of the SPARC Project are planned as follows
1 To establish a network of intensive care units with medical and nursing leaders who will participate in a collaborative program designed to standardize monitor and improve the care of patients resuscitated from out-of-hospital cardiac arrest
2 To develop a series of standardized protocols and processes for the care of patients following out-of-hospital cardiac arrest with particular emphasis on the delivery of post cardiac arrest mild hypothermia These protocols will be based on best evidence to date and will focus on the simplifying the processes required implement the recommended interventions
3 To conduct pragmatic clinical trials of the integrated post cardiac arrest protocol versus historical controls and study related patient outcomes such as survival to hospital discharge We will also look to provide a comprehensive assessment of in-hospital complications the incidence of presumed myocardial ischemic events causing cardiac arrest and to assess the causes of in-hospital and post discharge morbidity and mortality for the one year following discharge as a function of the presumed underlying cause of cardiac arrest and the in-hospital course
Unfortunately many of these patients will then die following hospital admission from one of a variety of complications of the initial cardiac arrest The in-hospital attrition rate is approximately 50 and is the result of short and longer-term organ damage suffered during the circulatory arrest as well as in-hospital complications including pulmonary neurological septic and multi-organ dysfunction related complications
Although guidelines for specific aspects of intensive care therapy of critically ill patients have been developed for example ventilation guidelines sepsis prevention and therapy guidelines treatment of metabolic disorders etc practical guidelines which are specifically aimed at the investigation and treatment of patients resuscitated from out-of-hospital cardiac arrest do not currently exist
Preliminary studies in press suggest that a program of comprehensive and consistent adherence to a specific set of standard procedures in intensive care units can lead to a substantial improvement in the survival of patients resuscitated from cardiac arrest One recent example is a study from Oslo Norway which showed substantial improvements in survival to discharge following out-of-hospital cardiac arrest after a set of informal guidelines were adopted by participating intensive care units
There are multiple reasons for the lack of clearly articulated guidelines and protocols for the investigation and treatment of patients resuscitated following cardiac arrest however the two most obvious are lack of understanding of the current recommended best practices and practical impediments to their efficient implementation in all units
The Resuscitation Outcomes Consortium ROC an NIH funded multi-centre effort seeks to randomize over 10000 patients in selected North American sites to study specific interventions designed to improve long term survival in patients with out-of-hospital cardiac arrest As part of this consortium intensive care units in the ROC hospitals are being invited to join a new best practice initiative entitled Strategies for Post Arrest Care in the ICU SPARC
Working with more than 50 hospitals across Ontario the objectives of the SPARC Project are planned as follows
1 To establish a network of intensive care units with medical and nursing leaders who will participate in a collaborative program designed to standardize monitor and improve the care of patients resuscitated from out-of-hospital cardiac arrest
2 To develop a series of standardized protocols and processes for the care of patients following out-of-hospital cardiac arrest with particular emphasis on the delivery of post cardiac arrest mild hypothermia These protocols will be based on best evidence to date and will focus on the simplifying the processes required implement the recommended interventions
3 To conduct pragmatic clinical trials of the integrated post cardiac arrest protocol versus historical controls and study related patient outcomes such as survival to hospital discharge We will also look to provide a comprehensive assessment of in-hospital complications the incidence of presumed myocardial ischemic events causing cardiac arrest and to assess the causes of in-hospital and post discharge morbidity and mortality for the one year following discharge as a function of the presumed underlying cause of cardiac arrest and the in-hospital course
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None