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

Heart Arrest Clinical Trial

Official title:

Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve and Early Versus Delayed Analysis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00394706
• Other study ID #: 29919
• Secondary ID: HL077863
• Status: Terminated
• Phase: Phase 3
• Start date: June 2007
• Est. completion date: July 2010

Study information

• Verified date: July 2018
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11738
• Est. completion date: July 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Arrest

Intervention

Device:
• Impedance Threshold Device (ITD)
Use of Impedance Threshold Device (ITD)
• 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.
• 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.

Locations

Country	Name	City	State
Canada	University of Ottawa/University of British Columbia Collaborative RCC, Ottawa Health Research	Ottawa	Ontario
Canada	Toronto Regional Resuscitation Research Out-of-Hospital Network, University of Toronto	Toronto	Ontario
United States	Alabama Resuscitation Center	Birmingham	Alabama
United States	Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center	Dallas	Texas
United States	Milwaukee Resuscitation Network, Medical College of Wisconsin	Milwaukee	Wisconsin
United States	The Pittsburgh Resuscitation Network, University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University	Portland	Oregon
United States	UCSD-San Diego Resuscitation Center	San Diego	California
United States	Seattle-King County Center for Resuscitation Research, University of Washington	Seattle	Washington

Sponsors (7)

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

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

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. — View 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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to Hospital Discharge With Satisfactory Function (Modified Rankin Scale [MRS] of Less Than or Equal to 3).	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	Survival to Hospital Discharge		Survival to hospital discharge or death before discharge
Secondary	Modified Rankin Score at 6 Months After 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
Secondary	Adult Lifestyle and Function Version of Mini-Mental Status Exam at 6 Months	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
Secondary	Health Utilities Index III Score and Geriatric Depression Scale Score 6 Months	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

External Links

•   Click here for more information about the ROC PRIMED Trial