Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve

• Survival to Hospital Discharge [ Time Frame: Survival to hospital discharge or death before discharge ] [ Designated as safety issue: Yes ]
• Modified Rankin Score at 6 Months After Hospital Discharge [ Time Frame: 6 months post hospital discharge ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: Yes ]
• Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months [ Time Frame: 6 months post hospital discharge ] [ Designated as safety issue: Yes ]

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.

• 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

• Aufderheide TP, Nichol G, Rea TD, Brown SP, Leroux BG, Pepe PE, Kudenchuk PJ, Christenson J, Daya MR, Dorian P, Callaway CW, Idris AH, Andrusiek D, Stephens SW, Hostler D, Davis DP, Dunford JV, Pirrallo RG, Stiell IG, Clement CM, Craig A, Van Ottingham L, Schmidt TA, Wang HE, Weisfeldt ML, Ornato JP, Sopko G; Resuscitation Outcomes Consortium (ROC) Investigators. A trial of an impedance threshold device in out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep 1;365(9):798-806.
• Stiell IG, Nichol G, Leroux BG, Rea TD, Ornato JP, Powell J, Christenson J, Callaway CW, Kudenchuk PJ, Aufderheide TP, Idris AH, Daya MR, Wang HE, Morrison LJ, Davis D, Andrusiek D, Stephens S, Cheskes S, Schmicker RH, Fowler R, Vaillancourt C, Hostler D, Zive D, Pirrallo RG, Vilke GM, Sopko G, Weisfeldt M; ROC Investigators. Early versus later rhythm analysis in patients with out-of-hospital cardiac arrest. N Engl J Med. 2011 Sep;365(9):787-97.

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.

• 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