Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis - Full Text View

Purpose

The purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.

Condition	Intervention	Phase
Heart Arrest	Device: Impedance Threshold Device (ITD) Device: Sham ITD Other: Analyze early Other: Analyze later	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Factorial Assignment, Efficacy Study

Official Title:	ROC Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis

Further study details as provided by University of Washington:

Primary Outcome Measures:

Survival to hospital discharge with a Modified Rankin Scale (MRS) of less than or equal to 3 [ Time Frame: Hospital discharge or death prior to discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Survival to discharge [ Time Frame: 6 months post hospital discharge ] [ Designated as safety issue: Yes ]
MRS at 3 and 6 months after hospital discharge [ Time Frame: 6 months post hospital discharge ] [ Designated as safety issue: Yes ]
Adult Lifestyle and Function version of Mini-Mental Status Exam at 1, 3 and 6 months [ Time Frame: 6 months post hospital discharge ] [ Designated as safety issue: Yes ]
Health Utilities Index III score and Geriatric Depression Scale score at 3 and 6 months [ Time Frame: 6 months post hospital discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	14154
Study Start Date:	May 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Use of Impedance Threshold Device	Device: Impedance Threshold Device (ITD) Use of Impedance Threshold Device (ITD)
2: Sham Comparator Sham ITD	Device: Sham ITD Sham ITD
3 Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Other: Analyze early Upon EMS arrival at the scene of a non-traumatic cardiac arrest, an assessment of the cardiac rhythm is done to determine whether a defibrillatory shock is required.
4 Analyze late. Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.	Other: Analyze later Upon EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is given prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.

Detailed Description:

The first treatment involves using a device called the Impedance Threshold Device (ITD). The ITD is a small hard plastic device about the size of a fist that is attached to the face mask or airway tube used during CPR. The ITD provides increased blood flow back to the heart during chest compressions until the heart starts beating on its own again.

The other treatment involves the amount of cardiopulmonary resuscitation (CPR) given before the emergency medical services providers first look at the heart rhythm to determine if a shock is needed. A person would receive either about 30 seconds of chest compressions or about 3 minutes of compressions before checking the heart rhythm. Giving some compressions before checking the heart rhythm increases the blood being circulated to the body. Researchers do not know how many compressions before the rhythm check are necessary to save more lives.

Depending on the circumstances of the cardiac arrest a person may receive only one of these treatments or both of these treatments. The purpose of the research study is to determine if more people live when either the real ITD is used or if additional CPR is given before looking at the heart rhythm the first time. This study is being conducted in 9 different areas throughout the United States and Canada by the Resuscitation Outcomes Consortium (ROC). About 15,000 patients will be enrolled in this research study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All persons of local age of consent or older who suffer non-traumatic cardiopulmonary arrest outside of the hospital in the study communities with defibrillation and/or delivery of chest compressions provided by emergency medical service (EMS) providers dispatched to the scene and do not meet any of the exclusion criteria.

Exclusion Criteria:

Common:

Do not attempt resuscitation (DNAR) orders
Blunt, penetrating, or burn-related injury
Patients with exsanguinations
Known prisoners
Known pregnancy
Non-ROC EMS agency/provider

For Analyzing Late versus Early

EMS-witnessed arrests
Non-EMS rhythm analysis (AED placed by police or lay responder is an exclusion but CPR by lay or other non-EMS responders is not)

For ITD:

Tracheostomy present
CPR performed with the mechanical compression "Autopulse" device.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394706

Contacts


Contact: Scott Emerson, MD, PhD	206-685-1302	semerson@u.washington.edu

Contact: Judy L Powell, BSN	206-685-1302	jlpowell@u.washington.edu

Locations


United States, Alabama
	Alabama Resuscitation Center, University of Alabama	Recruiting
	Birmingham, Alabama, United States, 35249
	Contact: Jeff Kerby, MD
	Principal Investigator: Jeffrey Kerby, MD

United States, California
	UCSD-San Diego Resuscitation Center	Recruiting
	San Diego, California, United States, 92103
	Contact: Dan Davis, MD
	Principal Investigator: Dan Davis, MD

United States, Oregon
	Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University	Recruiting
	Portland, Oregon, United States, 97239
	Contact: Terri A Schmidt, MD
	Principal Investigator: Terri A Schmidt, MD

United States, Pennsylvania
	The Pittsburgh Resuscitation Network, University of Pittsburgh	Recruiting
	Pittsburgh, Pennsylvania, United States, 15213
	Contact: Clifton W Callaway, MD
	Principal Investigator: Clifton W Callaway, MD

United States, Texas
	Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center	Not yet recruiting
	Dallas, Texas, United States, 75390
	Contact: Ahamed H Idris, MD
	Principal Investigator: Ahamed H Idris, 75390

United States, Washington
	Seattle-King County Center for Resuscitation Research, University of Washington	Recruiting
	Seattle, Washington, United States, 98195
	Contact: Peter J Kudenchuk, MD
	Principal Investigator: Peter J Kudenchuk, MD

United States, Wisconsin
	Milwaukee Resuscitation Network, Medical College of Wisconsin	Recruiting
	Milwaukee, Wisconsin, United States, 53226
	Contact: Tom P Aufderheide, MD
	Principal Investigator: Tom P Aufderheide, MD

Canada, Ontario
	University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research	Recruiting
	Ottawa, Ontario, Canada, K1Y4E9
	Contact: Ian G Stiell, MD
	Principal Investigator: Ian G Stiell, MD
	Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto	Recruiting
	Toronto, Ontario, Canada, M5B1W8
	Contact: Arthur S Slutsky, MD
	Principal Investigator: Arthur S Slutsky, MD

Sponsors and Collaborators

University of Washington

National Institutes of Health (NIH)

National Institute of Neurological Disorders and Stroke (NINDS)

Canadian Institutes of Health Research (CIHR)

Defense Research and Development Canada

Heart and Stroke Foundation of Ontario

American Heart Association

Investigators


Study Chair:	Myron L Weisfeldt, MD	John Hopkins University

More Information

Click here for more information about the ROC PRIMED Trial This link exits the ClinicalTrials.gov site

Responsible Party:	ROC Clinical Trial Center-University of Washington ( Scott Emerson, MD, PhD )
Study ID Numbers:	29919
First Received:	October 30, 2006
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00394706
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Washington:

cardiac arrest

cardiopulmonary resuscitation

Study placed in the following topic categories:

Heart Diseases

Heart Arrest

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2008

Sponsors and Collaborators:	University of Washington National Institutes of Health (NIH) National Institute of Neurological Disorders and Stroke (NINDS) Canadian Institutes of Health Research (CIHR) Defense Research and Development Canada Heart and Stroke Foundation of Ontario American Heart Association
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00394706