Status:
COMPLETED
Pre-ROSC Intra-Nasal Cooling Effectiveness
Lead Sponsor:
BeneChill, Inc
Conditions:
Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- ≥18 years
- Collapse was witnessed
- No pulse
- Unresponsive to external stimuli
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00808236
Start Date
November 1 2008
End Date
September 1 2009
Last Update
June 10 2011
Active Locations (15)
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1
CHU St Pierre
Brussels, Belgium, 1000
2
Erasme Hospital (Free University of Brussels)
Brussels, Belgium, 1070
3
CHU de Tivoli
La Louvière, Belgium, 7100
4
UZ Gasthuisberg Leuven
Leuven, Belgium, B-3000