Pre-ROSC Intra-Nasal Cooling Effectiveness (PRINCE)

BeneChill

Status

Completed

Conditions

Cardiac Arrest

Treatments

Device: RhinoChill

Other: Control

Study type

Interventional

Funder types

Industry

Identifiers

NCT00808236

BC-CP1012

Details and patient eligibility

About

The purpose of the study was to demonstrate the safety and feasibility of early intranasal cooling prior to return of spontaneous circulation (ROSC) in the emergency medical services (EMS) environment. It was hypothesized that cooling during the resuscitation attempt would increase ROSC and subsequent survival. The study was not powered to demonstrate statistically-significant differences in any outcome parameter, but was intended as an exploratory study only.

Full description

Out of hospital cardiac arrest remains a significant cause of death. Mild hypothermia induced after resuscitation from cardiac arrest has been shown to improve neurologically intact survival. Studies in dogs and rodents have demonstrated improved outcomes when cooling is initiated intra-arrest.

The RhinoChill is a non-invasive cooling device through which rapid cooling is achieved via the intranasal delivery of an evaporative coolant into the nasopharynx. Due to its non-invasive and portable nature, the RhinoChill can be used to begin cooling earlier than other cooling devices.

Studies performed using the RhinoChill in a porcine model of cardiac arrest suggest that cooling with the RhinoChill prior to the first defibrillation attempt facilitates resuscitation and improves resuscitation rate and neurologically intact survival.

This study is being performed to assess the feasibility of using the RhinoChill device in the pre-hospital setting to improve resuscitation from cardiac arrest.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥18 years
Collapse was witnessed
No pulse
Unresponsive to external stimuli

Exclusion criteria

Have an etiology of cardiac arrest due to trauma, severe bleeding, drug overdose (OD), cerebrovascular accident (CVA), drowning, smoke inhalation, electrocution, hanging
Already hypothermic
Head trauma
Cannot place intra nasal catheters
Do Not Attempt to Resuscitate (DNAR) orders
Known or clinically apparent pregnancy
Have a known coagulopathy (except therapeutically induced)
Are known to have a need for supplemental oxygen
Achieve return of spontaneous circulation (ROSC) prior to initiating cooling
Are reached by emergency medical services (EMS) personnel more than 20 minutes after collapse