Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve
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|ClinicalTrials.gov Identifier: NCT00394706|
Recruitment Status : Terminated (Terminated because preliminary data suggested no difference in the strategies.)
First Posted : November 1, 2006
Results First Posted : April 18, 2012
Last Update Posted : August 9, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Heart Arrest||Device: Impedance Threshold Device (ITD) Device: Sham ITD Other: Analyze early Other: Analyze later||Phase 3|
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 (cardiopulmonary resuscitation). 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 CPR given before the emergency medical services (EMS) 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11738 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||July 2010|
Use of Impedance Threshold Device (ITD)
Device: Impedance Threshold Device (ITD)
Use of Impedance Threshold Device (ITD)
Sham Comparator: 2
Device: Sham ITD
Analyze early. Upon EMS (emergency medical services) 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 (cardiopulmonary resuscitation) 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.
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.
- Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3). [ Time Frame: Hospital discharge or death prior to discharge ]The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death). Subjects with a mRS scores of three or less (i.e. better) at the time of hospital discharge were considered to have a positive outcome, resulting in a binary measure.
- Survival to Hospital Discharge [ Time Frame: Survival to hospital discharge or death before discharge ]
- Modified Rankin Score at 6 Months After Hospital Discharge [ Time Frame: 6 months post hospital discharge ]The modified Rankin Score (mRS) measures the ability of patients to function independently. The scale goes from 0 (no symptoms) to 6 (death).
- Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months [ Time Frame: 6 months post hospital discharge ]The adult lifestyle and function interview (ALFI) version of the mini-mental status exam (MMSE) measures neurological status. The ALFI-MMSE has 23 items. It is scored from 0 to 22, with lower scores interpreted as being worse.
- Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months [ Time Frame: 6 months post hospital discharge ]The Health Utilities Index Mark 3 system was used to evaluate generic health related quality of life (HRQL). The interview-administered version of HUI3 requires completion of a maximum of 39 questions. The HUI3 consists of eight attributes of general health (vision, hearing, speech, mobility, dexterity, emotion, cognition, and pain) with five or six levels per attribute. For each respondent, health status is described as a vector that combines the levels of each attribute. This information is then converted into a utility score of HRQL on a scale from perfect health (1.0) to death (0).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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)
- Tracheostomy present
- CPR performed with the mechanical compression "Autopulse" device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394706
|United States, Alabama|
|Alabama Resuscitation Center|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|UCSD-San Diego Resuscitation Center|
|San Diego, California, United States, 92103|
|United States, Oregon|
|Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|The Pittsburgh Resuscitation Network, University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Texas|
|Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|United States, Washington|
|Seattle-King County Center for Resuscitation Research, University of Washington|
|Seattle, Washington, United States, 98195|
|United States, Wisconsin|
|Milwaukee Resuscitation Network, Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research|
|Ottawa, Ontario, Canada, K1Y4E9|
|Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto|
|Toronto, Ontario, Canada, M5B1W8|
|Study Chair:||Myron L Weisfeldt, MD||Johns Hopkins University|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Susanne May, Principal Investigator, University of Washington|
|Other Study ID Numbers:||
|First Posted:||November 1, 2006 Key Record Dates|
|Results First Posted:||April 18, 2012|
|Last Update Posted:||August 9, 2018|
|Last Verified:||July 2018|