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Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study (PRINCESS)

This study is currently recruiting participants.
Verified May 2012 by Karolinska Institutet
Sponsor:
Collaborators:
Erasme University Hospital
BeneChill, Inc
Information provided by (Responsible Party):
Leif Svensson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01400373
First received: September 9, 2010
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Out-of-hospital Cardiac Arrest
 Device: Prehospital intra-nasal cooling with RhinoChill
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PRINCESS - Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Neurologically intact survival (CPC-cerebral performance categories scale 1-2) [ Time Frame: 90 days after cardiac arrest ] [ Designated as safety issue: No ]

    The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered "neurologically intact."

    1. - Good cerebral performance: little to no deficit.
    2. - Moderate cerebral disability: capable of independent activities of daily life
    3. - Severe cerebral disability: conscious, but dependent on others for daily support
    4. - Coma or vegetative state
    5. - Death or brain death


Secondary Outcome Measures:
  • Total survival [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Proportion of patients achieving Return of Spontaneous Circulation (ROSC). [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Time to target temperature of 32-34º Celsius [ Time Frame: 8-10 hours ] [ Designated as safety issue: No ]
  • Admitted alive to hospital [ Time Frame: 2-4 hours ] [ Designated as safety issue: No ]
    Proportion of patients that are admitted alive to hospital


Estimated Enrollment: 900
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Patients in the control group standard advanced cardiac life support care. Patients that achieve return of spontaneous circulation will be treated with hypothermia according to current guidelines upon arrival at the intensive care unit.
Experimental: Intervention
Intra-arrest trans-nasal cooling with RhinoChill will be initiated during advanced cardiac life support. In patients achieving return of spontaneous circulation, trans-nasal cooling will continue until systemic cooling is started at the intensive care unit.
 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Collapse was witnessed (heard or seen)
  • Do not have a pulse
  • Are unresponsive to external stimuli

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400373

Contacts
Contact: Leif Svensson, MD, PhD +46 8 616 19 18 leif.svensson@sodersjukhuset.se
Contact: Maaret Castrén, MD, PhD +46 8 616 39 54 maaret.castren@sodersjukhuset.se

Locations
Belgium
Department of Intensive Care, Erasme University Hospital Recruiting
Brussels, Belgium
Contact: Fabio Taccone, MD     +322 555 5587     ftaccone@ulb.ac.be    
Sweden
Stockholm Prehospital Centre, Karolinska Institutet Södersjukhuset Recruiting
Stockholm, Sweden, 11883
Contact: Leif Svensson, MD. PhD     +46 8 616 19 18     leif.svensson@sodersjukhuset.se    
Contact: Maaret Castrén, MD. PhD.     + 46 8 616 39 54     maaret.castren@sodersjukhuset.se    
Principal Investigator: Leif Svensson, MD. PhD            
Sponsors and Collaborators
Karolinska Institutet
Erasme University Hospital
BeneChill, Inc
  More Information

Publications:

Responsible Party: Leif Svensson, Leif Svensson, MD, PhD. Associate Professor in Cardiology. Karolinska Institutet, Södersjukhuset., Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01400373     History of Changes
Obsolete Identifiers: NCT01328847
Other Study ID Numbers: PRINCESS 2010/383-32
Study First Received: September 9, 2010
Last Updated: May 29, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Hypothermia, induced
Intra-arrest cooling
Cardiac arrest
Prehospital emergency care
Emergency Medical Services

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013