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

• ClinicalTrials.gov Identifier: NCT00394706
• Recruitment Status: Terminated
• First Posted: November 1, 2006
• Results First Posted: April 18, 2012
• Last Update Posted: August 9, 2018
• Sponsor: University of Washington
• Collaborators: 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
• Information provided by (Responsible Party): Susanne May, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart Arrest	Device: Impedance Threshold Device (ITD); Device: Sham ITD; Other: Analyze early; Other: Analyze later	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 11738 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Use of Impedance Threshold Device (ITD)	Device: Impedance Threshold Device (ITD); Use of Impedance Threshold Device (ITD)
Sham Comparator: 2; Sham ITD	Device: Sham ITD; 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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Survival to Hospital Discharge [ Time Frame: Survival to hospital discharge or death before discharge ]
2. 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).
3. 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.
4. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

Canada, Ontario

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

Sponsors and Collaborators

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

Investigators

• Study Chair: Myron L Weisfeldt, MD; Johns Hopkins University

More Information

Additional Information:

Click here for more information about the ROC PRIMED Trial 

Publications of Results:

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.

Other Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

• Responsible Party: Susanne May, Principal Investigator, University of Washington
• ClinicalTrials.gov Identifier: NCT00394706
• Other Study ID Numbers: 29919; HL077863
• First Posted: November 1, 2006
• Results First Posted: April 18, 2012
• Last Update Posted: August 9, 2018
• Last Verified: July 2018

Keywords provided by Susanne May, University of Washington:

cardiac arrest; cardiopulmonary resuscitation

Additional relevant MeSH terms:

Heart Arrest; Heart Diseases; Cardiovascular Diseases