- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02007499
Pre-arrival Instructions Effect on Bystander Cardiopulmonary Resuscitation (CPR).
The Effect of Pre-arrival Instructions on the Rate of Bystander Cardiopulmonary Resuscitation (CPR) for Patients in "Out of Hospital Cardiac Arrest (OHCA)".
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The City of Milwaukee and surrounding communities combine to form Milwaukee County covering 241 square miles and serving approximately 959,521 people. Milwaukee County includes 19 separate municipalities. Community demographics and other characteristics have remained largely stable for the past decade.
The study will take place in Milwaukee County from 2009 - 2013 in the communities providing Cardiopulmonary Resuscitation (CPR) pre-arrival instructions: West Allis and Oak Creek.
In Milwaukee County Basic Live Support (BLS) shall be started on all patients in cardiac arrest with the exception of victims with: decapitation; rigor mortis; evidence of tissue decomposition; dependent lividity; presence of a valid Do-Not-Resuscitate (DNR) or Physician Orders for Life-Sustaining Treatment (POLST); fire victim with full thickness burns to 90% or greater body surface area; hypothermic patients with signs of frozen tissue, rigid airway, ice formation in mouth, or chest noncompliant for Cardiopulmonary Resuscitation (CPR). The system standard is: Cardiopulmonary Resuscitation (CPR) will be provided whenever patient is pulseless; compressions at least 100/minute; hands on chest more than 75% of time; minimum compression depth of 2 inches in adults 75% of the time.
Therefore, the investigators will analyze data to assess how Cardiopulmonary Resuscitation (CPR) pre-arrival instructions may have affected the probability of receiving bystander Cardiopulmonary Resuscitation (CPR).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients 21 years old or older
- Presumed cardiac origin as indicated on the Milwaukee County Emergency Medical Services (MCEMS) report
- Non-Emergency Medical Services (EMS) witnessed arrest
Exclusion Criteria:
- Patients younger than 21 years old
- Patients who are "obviously dead" (decomposition, rigor mortis, decapitation, or other)
- Trauma victims, including hanging and burns
- Patients with cardiac arrests clearly of other non-cardiac origin including drug overdose, carbon monoxide poisoning, drowning, exsanguination, electrocution, asphyxia, hypoxia related to respiratory disease, cerebrovascular accident and documented terminal illness
- Patients determined to be a do-not-resuscitate (DNR) upon arrival of Emergency Medical Services (EMS) providers
- Cardiopulmonary Resuscitation (CPR) by someone other than Emergency Medical Services (EMS) who is a trained first responder or health care provider with a predetermined duty to provide care.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Community 1 Before
Pre-arrival Cardiopulmonary Resuscitation (CPR) instruction for bystander Before Intervention Group in Community 1
|
|
|
Community 1 After
Pre-arrival Cardiopulmonary Resuscitation (CPR) instruction for bystander After Intervention Group in Community 1
|
Out of Hospital Cardiac Arrest (OHCA) Pre-Arrival Instructions (PAI)
|
|
Community 2 Before
Pre-arrival Cardiopulmonary Resuscitation (CPR) instruction for bystander Before Intervention Group in Community 2
|
|
|
Community 2 After
Pre-arrival Cardiopulmonary Resuscitation (CPR) instruction for bystander After Intervention Group in Community 2
|
Out of Hospital Cardiac Arrest (OHCA) Pre-Arrival Instructions (PAI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Bystander Cardiopulmonary Resuscitation (CPR) in Out of Hospital Cardiac Arrest (OHCA)
Time Frame: Up to 2 years prior to intervention and up to 2 years post intervention
|
The overall goal of this study is to determine the rate of bystander Cardiopulmonary Resuscitation (CPR) before and after implementation of Cardiopulmonary Resuscitation (CPR) pre-arrival instructions program in Milwaukee County
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Up to 2 years prior to intervention and up to 2 years post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival to Hospital Discharge or to December, 31 2013 Whichever Comes First
Time Frame: Up to 2 years prior to intervention and up to 2 years post intervention
|
Explore any relationship to age and gender of the patient, location of arrest, time of year, and other indicators known to affect survival on the overall difference in patient discharge.
|
Up to 2 years prior to intervention and up to 2 years post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Khalid A. Ateyyah, MD, SBEM, Medical College of Wisconsin
Publications and helpful links
General Publications
- Cummins RO, Chamberlain DA, Abramson NS, Allen M, Baskett P, Becker L, Bossaert L, Delooz H, Dick W, Eisenberg M, et al. Recommended guidelines for uniform reporting of data from out-of-hospital cardiac arrest: the Utstein Style. Task Force of the American Heart Association, the European Resuscitation Council, the Heart and Stroke Foundation of Canada, and the Australian Resuscitation Council. Ann Emerg Med. 1991 Aug;20(8):861-74. No abstract available.
- Abella BS, Aufderheide TP, Eigel B, Hickey RW, Longstreth WT Jr, Nadkarni V, Nichol G, Sayre MR, Sommargren CE, Hazinski MF; American Heart Association. Reducing barriers for implementation of bystander-initiated cardiopulmonary resuscitation: a scientific statement from the American Heart Association for healthcare providers, policymakers, and community leaders regarding the effectiveness of cardiopulmonary resuscitation. Circulation. 2008 Feb 5;117(5):704-9. doi: 10.1161/CIRCULATIONAHA.107.188486. Epub 2008 Jan 14. No abstract available.
- Berdowski J, Berg RA, Tijssen JG, Koster RW. Global incidences of out-of-hospital cardiac arrest and survival rates: Systematic review of 67 prospective studies. Resuscitation. 2010 Nov;81(11):1479-87. doi: 10.1016/j.resuscitation.2010.08.006. Epub 2010 Sep 9.
- Song KJ, Shin SD, Park CB, Kim JY, Kim DK, Kim CH, Ha SY, Eng Hock Ong M, Bobrow BJ, McNally B. Dispatcher-assisted bystander cardiopulmonary resuscitation in a metropolitan city: a before-after population-based study. Resuscitation. 2014 Jan;85(1):34-41. doi: 10.1016/j.resuscitation.2013.06.004. Epub 2013 Jun 17.
- Nichol G, Thomas E, Callaway CW, Hedges J, Powell JL, Aufderheide TP, Rea T, Lowe R, Brown T, Dreyer J, Davis D, Idris A, Stiell I; Resuscitation Outcomes Consortium Investigators. Regional variation in out-of-hospital cardiac arrest incidence and outcome. JAMA. 2008 Sep 24;300(12):1423-31. doi: 10.1001/jama.300.12.1423.
- Liu JM, Yang Q, Pirrallo RG, Klein JP, Aufderheide TP. Hospital variability of out-of-hospital cardiac arrest survival. Prehosp Emerg Care. 2008 Jul-Sep;12(3):339-46. doi: 10.1080/10903120802101330.
- Nichol G, Rumsfeld J, Eigel B, Abella BS, Labarthe D, Hong Y, O'Connor RE, Mosesso VN, Berg RA, Leeper BB, Weisfeldt ML; American Heart Association Emergency Cardiovascular Care Committee; American Heart Association Council on Cardiopulmonary, Perioperative, and Critical Care; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology; Quality of Care and Outcomes Research Interdisciplinary Working Group. Essential features of designating out-of-hospital cardiac arrest as a reportable event: a scientific statement from the American Heart Association Emergency Cardiovascular Care Committee; Council on Cardiopulmonary, Perioperative, and Critical Care; Council on Cardiovascular Nursing; Council on Clinical Cardiology; and Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation. 2008 Apr 29;117(17):2299-308. doi: 10.1161/CIRCULATIONAHA.107.189472. Epub 2008 Apr 14.
- Lateef F, Anantharaman V. Bystander cardiopulmonary resuscitation in prehospital cardiac arrest patients in Singapore. Prehosp Emerg Care. 2001 Oct-Dec;5(4):387-90. doi: 10.1080/10903120190939562.
- Rea TD, Eisenberg MS, Culley LL, Becker L. Dispatcher-assisted cardiopulmonary resuscitation and survival in cardiac arrest. Circulation. 2001 Nov 20;104(21):2513-6. doi: 10.1161/hc4601.099468.
- Sasson C, Magid DJ, Chan P, Root ED, McNally BF, Kellermann AL, Haukoos JS; CARES Surveillance Group. Association of neighborhood characteristics with bystander-initiated CPR. N Engl J Med. 2012 Oct 25;367(17):1607-15. doi: 10.1056/NEJMoa1110700.
- Billittier AJ 4th, Lerner EB, Tucker W, Lee J. The lay public's expectations of prearrival instructions when dialing 9-1-1. Prehosp Emerg Care. 2000 Jul-Sep;4(3):234-7. doi: 10.1080/10903120090941254.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00021202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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