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

July 12, 2018 updated by: Susanne May, University of Washington

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11738

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y4E9
        • University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research
      • Toronto, Ontario, Canada, M5B1W8
        • Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Alabama Resuscitation Center
    • California
      • San Diego, California, United States, 92103
        • UCSD-San Diego Resuscitation Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • The Pittsburgh Resuscitation Network, University of Pittsburgh
    • Texas
      • Dallas, Texas, United States, 75390
        • Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Seattle-King County Center for Resuscitation Research, University of Washington
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Milwaukee Resuscitation Network, Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Hospital discharge or death prior to discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival to Hospital Discharge
Time Frame: Survival to hospital discharge or death before discharge
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).
6 months post hospital discharge
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.
6 months post hospital discharge
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).
6 months post hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
National Institute of Neurological Disorders and Stroke (NINDS)
American Heart Association
Heart and Stroke Foundation of Canada
Defence Research and Development Canada

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 30, 2006

First Submitted That Met QC Criteria

October 30, 2006

First Posted (Estimate)

November 1, 2006

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

July 12, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29919
  • HL077863

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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