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

University of Washington

Status and phase: Terminated; Phase 3

Conditions: Heart Arrest

Treatments: Device: Impedance Threshold Device (ITD); Other: Analyze later; Other: Analyze early; Device: Sham ITD

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00394706

29919

HL077863

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,738 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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11,738 participants in 4 patient groups

1

Experimental group

Description:

Use of Impedance Threshold Device (ITD)

Treatment:

Device: Impedance Threshold Device (ITD)

2

Sham Comparator group

Description:

Sham ITD

Treatment:

Device: Sham ITD

3

Other group

Description:

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.

Treatment:

Other: Analyze early

4

Other group

Description:

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.

Treatment:

Other: Analyze later