Status:
TERMINATED
Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Heart Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 wh...
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 tub...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
11738 Patients enrolled
Trial Details
Trial ID
NCT00394706
Start Date
June 1 2007
End Date
July 1 2010
Last Update
August 9 2018
Active Locations (9)
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1
Alabama Resuscitation Center
Birmingham, Alabama, United States, 35294
2
UCSD-San Diego Resuscitation Center
San Diego, California, United States, 92103
3
Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
Portland, Oregon, United States, 97239
4
The Pittsburgh Resuscitation Network, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213