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Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study (PRINCESS)

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ClinicalTrials.gov Identifier: NCT01400373
Recruitment Status : Recruiting
First Posted : July 22, 2011
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
Erasme University Hospital
University Hospital Hradec Kralove
CHU de Charleroi
University Hospital, Lille
Karolinska University Hospital
BeneChill, Inc
Information provided by (Responsible Party):
Leif Svensson, Karolinska Institutet

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 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 or disease Intervention/treatment Phase
Out-of-hospital Cardiac Arrest Device: Prehospital intra-nasal cooling with RhinoChill Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRINCESS - Prehospital Resuscitation Intra Nasal Cooling Effectiveness Survival Study
Study Start Date : June 2010
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Neurologically intact survival (CPC-cerebral performance categories scale 1-2) [ Time Frame: 90 days after cardiac arrest ]

    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 :
  1. Total survival [ Time Frame: 90 days ]
  2. Proportion of patients achieving Return of Spontaneous Circulation (ROSC). [ Time Frame: 1 hour ]
  3. Time to target temperature of 32-34º Celsius [ Time Frame: 8-10 hours ]
  4. Admitted alive to hospital [ Time Frame: 2-4 hours ]
    Proportion of patients that are admitted alive to hospital



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01400373


Contacts
Contact: Leif Svensson, MD, PhD +46 8 616 10 00 leif.svensson@sodersjukhuset.se
Contact: Per Nordberg, MD, PhD +46 8 616 35 83 per.nordberg@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
Department of Cardiology, Karolinska Institutet, Södersjukhuset Recruiting
Stockholm, Sweden, 11883
Contact: Leif Svensson, MD. PhD    +46 8 616 19 18    leif.svensson@sodersjukhuset.se   
Contact: Per Nordberg, MD. PhD.    + 46 8 616 35 83    per.nordberg@sodersjukhuset.se   
Principal Investigator: Leif Svensson, MD. PhD         
Principal Investigator: Per Nordberg, MD. PhD         
Sponsors and Collaborators
Karolinska Institutet
Erasme University Hospital
University Hospital Hradec Kralove
CHU de Charleroi
University Hospital, Lille
Karolinska University Hospital
BeneChill, Inc

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
First Posted: July 22, 2011    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Leif Svensson, 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