NCT00394706

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11,738 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Arrest

Interventions

Type	Name	Description
DEVICE	Impedance Threshold Device (ITD)	Use of Impedance Threshold Device (ITD)
DEVICE	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.
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.

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-11-01
• Completion: 2010-07-01
• First posted: 2006-11-01
• Last updated: 2018-08-09
• Results posted: 2012-04-18

Locations

9 sites across 2 countries: United States, Canada