Clinical trial NCT00394706: Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve
Official title: Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart Arrest
Keywords: cardiac arrest
cardiopulmonary resuscitation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Canadian Institutes of Health Research (CIHR)
name: Defence Research and Development Canada
name: Heart and Stroke Foundation of Canada
name: American Heart Association
First posted: 2006-11-01
Enrollment: 11738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 who live to hospital discharge. A cardiac arrest is when the heart stops pumping blood to the body.

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 (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.

Eligibility 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.

Primary outcomes:
measure: Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).
timeFrame: Hospital discharge or death prior to discharge
Secondary outcomes:
measure: Survival to Hospital Discharge
timeFrame: Survival to hospital discharge or death before discharge
measure: Modified Rankin Score at 6 Months After Hospital Discharge
timeFrame: 6 months post hospital discharge
measure: Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months
timeFrame: 6 months post hospital discharge
measure: Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months
timeFrame: 6 months post hospital discharge
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Resuscitation Center
state: Alabama
city: San Diego
country: United States
facility: UCSD-San Diego Resuscitation Center
state: California
city: Portland
country: United States
facility: Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: The Pittsburgh Resuscitation Network, University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Seattle-King County Center for Resuscitation Research, University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Milwaukee Resuscitation Network, Medical College of Wisconsin
state: Wisconsin
city: Ottawa
country: Canada
facility: University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
state: Ontario
city: Toronto
country: Canada
facility: Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
state: Ontario
Study officials:
affiliation: Johns Hopkins University
name: Myron L Weisfeldt, MD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1056/NEJMoa1010821.
citation: 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 1;365(9):787-97. doi: 10.1056/NEJMoa1010076.
citation: Kawano T, Grunau B, Scheuermeyer FX, Gibo K, Fordyce CB, Lin S, Stenstrom R, Schlamp R, Jenneson S, Christenson J. Intraosseous Vascular Access Is Associated With Lower Survival and Neurologic Recovery Among Patients With Out-of-Hospital Cardiac Arrest. Ann Emerg Med. 2018 May;71(5):588-596. doi: 10.1016/j.annemergmed.2017.11.015. Epub 2018 Jan 6.
citation: Ho ML, Gatien M, Vaillancourt C, Whitham V, Stiell IG. Utility of prehospital electrocardiogram characteristics as prognostic markers in out-of-hospital pulseless electrical activity arrests. Emerg Med J. 2018 Feb;35(2):89-95. doi: 10.1136/emermed-2017-206878. Epub 2017 Oct 21.
citation: Reynolds JC, Grunau BE, Rittenberger JC, Sawyer KN, Kurz MC, Callaway CW. Association Between Duration of Resuscitation and Favorable Outcome After Out-of-Hospital Cardiac Arrest: Implications for Prolonging or Terminating Resuscitation. Circulation. 2016 Dec 20;134(25):2084-2094. doi: 10.1161/CIRCULATIONAHA.116.023309. Epub 2016 Oct 19.
citation: Zheng R, Luo S, Liao J, Liu Z, Xu J, Zhan H, Liao X, Xiong Y, Idris A. Conversion to shockable rhythms is associated with better outcomes in out-of-hospital cardiac arrest patients with initial asystole but not in those with pulseless electrical activity. Resuscitation. 2016 Oct;107:88-93. doi: 10.1016/j.resuscitation.2016.08.008. Epub 2016 Aug 21.
citation: Idris AH, Guffey D, Pepe PE, Brown SP, Brooks SC, Callaway CW, Christenson J, Davis DP, Daya MR, Gray R, Kudenchuk PJ, Larsen J, Lin S, Menegazzi JJ, Sheehan K, Sopko G, Stiell I, Nichol G, Aufderheide TP; Resuscitation Outcomes Consortium Investigators. Chest compression rates and survival following out-of-hospital cardiac arrest. Crit Care Med. 2015 Apr;43(4):840-8. doi: 10.1097/CCM.0000000000000824.
citation: Stiell IG, Brown SP, Nichol G, Cheskes S, Vaillancourt C, Callaway CW, Morrison LJ, Christenson J, Aufderheide TP, Davis DP, Free C, Hostler D, Stouffer JA, Idris AH; Resuscitation Outcomes Consortium Investigators. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation. 2014 Nov 25;130(22):1962-70. doi: 10.1161/CIRCULATIONAHA.114.008671. Epub 2014 Sep 24.