Status:
COMPLETED
Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Erasme University Hospital
University Hospital Hradec Kralove
Conditions:
Out-of-hospital Cardiac Arrest
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
Promising result of intra-arrest cooling on neurological intact survival in cardiac arrest patients has recently been published in the PRINCE-study in Circulation 2010. The main purpose of this study...
Detailed Description
Background: The RhinoChill Device is a non-invasive, portable cooling device through which rapid cooling is achieved via the trans-nasal delivery of an evaporative coolant into the nasopharynx. Anima...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Collapse was witnessed (heard or seen)
- Do not have a pulse
- Are unresponsive to external stimuli
Exclusion
- Age ≥80 years
- Have an etiology of cardiac arrest due to trauma, severe bleeding, drug overdose, cerebrovascular accident, drowning, smoke inhalation, electrocution, hanging
- Already hypothermic (e.g., avalanche victim; found in the snow)
- Have an obvious barrier to placing intra nasal catheters (e.g., intranasal obstruction)
- Do Not Attempt to Resuscitate (DNAR) orders
- Have a terminal disease
- Known or clinically apparent pregnancy
- Have a known coagulopathy (except therapeutically induced)
- Are known to have a need for supplemental oxygen
- Achieve ROSC prior to randomization
- Response time (call to arrival) of the ambulance \> 15 minutes
Key Trial Info
Start Date :
July 6 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT01400373
Start Date
July 6 2010
End Date
April 30 2018
Last Update
June 29 2018
Active Locations (2)
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1
Department of Intensive Care, Erasme University Hospital
Brussels, Belgium
2
Department of Cardiology, Karolinska Institutet, Södersjukhuset
Stockholm, Sweden, 11883