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Pre-ROSC Intra-Nasal Cooling Effectiveness

NCT00808236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-06-10

Study results available
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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. 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.

Conditions

  • Cardiac Arrest

Interventions

DEVICE

RhinoChill

Nasal catheters are placed and cooling is begun during the resuscitation attempt

OTHER

Control

Advanced cardiac life support according to American Heart Association \& European Resuscitation Council 2005 Guidelines

Sponsors & Collaborators

  • BeneChill, Inc

    lead INDUSTRY

Principal Investigators

  • Denise Barbut, MD · BeneChill, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-06-30
Completion
2009-09-30

Countries

  • Belgium
  • Czechia
  • Germany
  • Italy
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808236 on ClinicalTrials.gov