Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot

University of Washington

Status: Completed

Conditions: Cardiac Arrest

Treatments: Device: Sham Remote Ischemic Conditioning; Device: Active Remote Ischemic Conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT04265807

STUDY00005176

Details and patient eligibility

About

Following resuscitation from out-of-hospital cardiac arrest (OHCA), reperfusion injury can cause cell damage in the heart and brain. Remote ischemic conditioning (RIC) consists of intermittent application of a device such as a blood pressure cuff to a limb to induce non-lethal ischemia. Studies in animals with cardiac arrest as well as in humans with acute myocardial infarction suggest that RIC before or after restoration of blood flow may reduce injury to the heart and improve outcomes but this has not been proven in humans who have had OHCA. The RICE pilot study is a single-center study to assess the feasibility of application of RIC in the emergency department setting for patients transported to the hospital after resuscitation from OHCA.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Included will be those with:

1. Age 18 years or more;
2. Defibrillation by laypersons or defibrillation and/or chest compressions by EMS providers dispatched to the scene;
3. Non-traumatic etiology of arrest, defined as without concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination;
4. Spontaneous circulation upon emergency department arrival;
5. No response to verbal commands; and
6. Ongoing or planned induced hypothermia.

Excluded will be those with:

1. STEMI indicated on first 12-lead ECG obtained after restoration of circulation, defined as ST-elevation of ≥2 mm in two or more contiguous ECG leads;
2. Written do not attempt resuscitation (DNAR) reported to providers before randomization;
3. Drowning or hypothermia as cause of arrest;
4. Known prisoner or pregnant; or
5. Dialysis fistula in either upper extremity; or
6. Pre-existing amputation of upper extremity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on an upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods.

Treatment:

Device: Active Remote Ischemic Conditioning

Control Group

Sham Comparator group

Description:

The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group.

Treatment:

Device: Sham Remote Ischemic Conditioning