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

This study has been terminated.
(Terminated because preliminary data suggested no difference in the strategies.)
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00394706
First received: October 30, 2006
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Heart Arrest
Device: Impedance Threshold Device (ITD)
Device: Sham ITD
Other: Analyze early
Other: Analyze later
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 ] [ 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). 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:
  • 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 ]

Enrollment: 11738
Study Start Date: June 2007
Study Completion Date: July 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394706

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
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:
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, ROC Investigators. A trial of an impedance threshold device in out-of-hospital cardiac arrest. New England Journal of Medicine 2011; 365:798-806

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susanne May, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00394706     History of Changes
Other Study ID Numbers: 29919-A, HL077863
Study First Received: October 30, 2006
Results First Received: March 23, 2012
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Washington:
cardiac arrest
cardiopulmonary resuscitation

Additional relevant MeSH terms:
Heart Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014