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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT02007499
Other study ID # PRO00021202
Secondary ID
Status Unknown status
Phase N/A
First received November 25, 2013
Last updated December 5, 2013
Start date January 2009
Est. completion date December 2013

Study information

Verified date December 2013
Source Medical College of Wisconsin
Contact Khalid A. Ateyyah, MD, SBEM
Phone +1 (414) 324-2995
Email dr.k3321@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators hypothesized that pre-arrival instructions would increase the likelihood of bystanders performing Cardiopulmonary Resuscitation (CPR).


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).


Recruitment information / eligibility

Status Unknown status
Enrollment 4000
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (11)

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 scientifi — View Citation

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 S — View Citation

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. — View Citation

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 America — View Citation

Lateef F, Anantharaman V. Bystander cardiopulmonary resuscitation in prehospital cardiac arrest patients in Singapore. Prehosp Emerg Care. 2001 Oct-Dec;5(4):387-90. — View Citation

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. — View Citation

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, Perioperati — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of bystander Cardiopulmonary Resuscitation (CPR) in Out of Hospital Cardiac Arrest (OHCA) 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 January, 01 2009 - December, 31 2013
Secondary Survival to hospital discharge or to December, 31 2013 whichever comes first 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. January, 01 2009 - December, 31 2013
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