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Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study

NCT01400373 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2018-06-29

No results posted yet for this study

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 is to determine whether prehospital intra-nasal cooling initiated during resuscitation, in addition to systemic cooling at hospital, increases neurological intact survival measured as cerebral performance category score (CPC-score)at 90 days in witnessed cardiac arrests outside hospital.

Conditions

  • Out-of-hospital Cardiac Arrest

Interventions

DEVICE

Prehospital intra-nasal cooling with RhinoChill

Patients in the intervention group will receive prehospital intra-nasal cooling with RhinoChill as soon as possible during the resuscitation (i.e. intra-arrest). Intra-nasal cooling will be ongoing until systemic hypothermia is started at the intensive care unit.

Sponsors & Collaborators

  • Erasme University Hospital

    collaborator OTHER

  • University Hospital Hradec Kralove

    collaborator OTHER

  • CHU de Charleroi

    collaborator OTHER

  • University Hospital, Lille

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • BeneChill, Inc

    collaborator INDUSTRY

  • Karolinska Institutet

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-06
Primary Completion
2018-01-31
Completion
2018-04-30

Countries

  • Belgium
  • Sweden

Study Locations

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Entities

Companies

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 NCT01400373 on ClinicalTrials.gov