Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370461
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2006-08-29
Brief Title:
Basic Life Support Termination of Resuscitation Implementation Study
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2015-11
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:
None
Brief Summary:
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
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
Detailed Description:
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 PCPs 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 ie 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 374 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
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 ie 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 374 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
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