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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 : April 30, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

October 30, 2006
November 1, 2006
March 23, 2012
April 18, 2012
April 30, 2012
June 2007
November 2009   (Final data collection date for primary outcome measure)
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 with a Modified Rankin Scale (MRS) of < or = to 3.
Complete list of historical versions of study NCT00394706 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months [ Time Frame: 6 months post hospital discharge ]
Survival to discharge; MRS at 3 & 6 months after hospital discharge; Adult Lifestyle & Function version of Mini-Mental Status Exam at 1, 3 & 6 months; Health Utilities Index III score & Geriatric Depression Scale score at 3 & 6 months.
Not Provided
Not Provided
 
Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve
Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Heart Arrest
  • Device: Impedance Threshold Device (ITD)
    Use of Impedance Threshold Device (ITD)
  • Device: Sham ITD
    Sham ITD
  • 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.
  • 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.
  • Experimental: 1
    Use of Impedance Threshold Device (ITD)
    Intervention: Device: Impedance Threshold Device (ITD)
  • Sham Comparator: 2
    Sham ITD
    Intervention: Device: Sham ITD
  • 3
    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.
    Intervention: Other: Analyze early
  • 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.
    Intervention: Other: Analyze later

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11738
July 2010
November 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00394706
29919-A
HL077863
Yes
Not Provided
Not Provided
Susanne May, University of Washington
University of Washington
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Canadian Institutes of Health Research (CIHR)
  • Defence Research and Development Canada
  • Heart and Stroke Foundation of Canada
  • American Heart Association
Study Chair: Myron L Weisfeldt, MD Johns Hopkins University
University of Washington
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP