Pre-ROSC Intra-Nasal Cooling Effectiveness (PRINCE)

This study has been completed.
Sponsor:
Information provided by:
BeneChill, Inc
ClinicalTrials.gov Identifier:
NCT00808236
First received: December 11, 2008
Last updated: June 8, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Cardiac Arrest
Device: RhinoChill
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study

Resource links provided by NLM:


Further study details as provided by BeneChill, Inc:

Primary Outcome Measures:
  • Achieve Return of Spontaneous Circulation (ROSC) [ Time Frame: 1-hour after arrest ] [ Designated as safety issue: No ]
    ROSC was defined as the return of an organized rhythm on electrocardiography (ECG) with a palpable pulse that was maintained for at least 20 minutes.

  • Survived to Hospital Discharge [ Time Frame: 30 days after arrest ] [ Designated as safety issue: No ]
    The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.

  • Survived Neurologically-Intact [ Time Frame: 30-days after 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:
  • Primary Outcomes in Sub-group With VF/VT as First Rhythm [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
    ROSC, survival, and neurologically-intact survival

  • Time to Therapeutic Temperature [ Time Frame: within 8 hours after enrollment ] [ Designated as safety issue: No ]
    The therapeutic temperature range for treatment in cardiac arrest is considered to be 32-34C. Time to therapeutic temperature was taken as the first time in which 34C was measured. Tympanic and core temperatures were taken in all patients.

  • Length of Stay [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]

    Length of stay data for patients admitted to the hospital will be calculated for:

    1. Days on ventilator
    2. Days in intensive care without ventilator
    3. Days in general ward

  • Serious Adverse Events (SAEs) [ Time Frame: 7 days after arrest ] [ Designated as safety issue: Yes ]
    These were defined serious adverse events that are not direct sequelae of the cardiac arrest itself or the underlying cardiac disease. Therefore, these do not include recurrent arrests occcuring within 24 hours of resuscitation nor deaths due to lack of cardiac and/or neurological recovery.

  • 24-hour Adverse Events (AE) [ Time Frame: 24 hours after arrest ] [ Designated as safety issue: Yes ]
    These were all non-serious adverse events that occurred between the time of enrollment and 24 hours after resuscitation. These did not include a failure to achieve ROSC.


Enrollment: 200
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RhinoChill
Intra-arrest cooling with the RhinoChill during advanced cardiac life support
Device: RhinoChill
Nasal catheters are placed and cooling is begun during the resuscitation attempt
Other Name: intra-nasal cooling
Control
Advanced cardiac life support, only
Other: Control
Advanced cardiac life support according to American Heart Association & European Resuscitation Council 2005 Guidelines

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 in dogs and rodents have demonstrated improved outcomes when cooling is initiated intra-arrest.

The RhinoChill is a non-invasive cooling device through which rapid cooling is achieved via the intranasal delivery of an evaporative coolant into the nasopharynx. Due to its non-invasive and portable nature, the RhinoChill can be used to begin cooling earlier than other cooling devices.

Studies performed using the RhinoChill in a porcine model of cardiac arrest suggest that cooling with the RhinoChill prior to the first defibrillation attempt facilitates resuscitation and improves resuscitation rate and neurologically intact survival.

This study is being performed to assess the feasibility of using the RhinoChill device in the pre-hospital setting to improve resuscitation from cardiac arrest.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years
  • Collapse was witnessed
  • No pulse
  • Unresponsive to external stimuli

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808236

Locations
Belgium
Erasme Hospital (Free University of Brussels)
Brussels, Belgium, 1070
CHU St Pierre
Brussels, Belgium, 1000
CHU de Tivoli
La Louviere, Belgium, 7100
UZ Gasthuisberg Leuven
Leuven, Belgium, B-3000
CHR de la Citadelle
Liege, Belgium, 4000
Helig Hartzieknehuis Roeselare
Roeselare, Belgium, 8800
Czech Republic
Faculty Hospital Královské Vinohrady
Prague, Czech Republic, 10034
Germany
Medizinisches Zentrum Kreis Aachen gGmbH
Aachen, Germany, 52146
Charite Campus Virchow Klinikum
Berlin, Germany, 13353
Albert Ludwigs University Freiburg
Freiburg, Germany, 79106
Georg August-Universität Göttingen
Göttingen, Germany, 37086
Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle (Saale), Germany, 06120
Otto-von-Guericke-Universität Magdeburg
Magdeburg, Germany, 39120
Italy
A.O Ospedale San Gerardo di Monza
Monza, Italy, 20052
Sweden
Stockholm Prehospital Centrum
Stockholm, Sweden, 118 83
Sponsors and Collaborators
BeneChill, Inc
Investigators
Study Chair: Denise Barbut, MD BeneChill, Inc
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Becky Inderbitzen/Vice President Clinical Affairs, BeneChill
ClinicalTrials.gov Identifier: NCT00808236     History of Changes
Other Study ID Numbers: BC-CP1012
Study First Received: December 11, 2008
Results First Received: May 21, 2010
Last Updated: June 8, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Belgium: Institutional Review Board

Keywords provided by BeneChill, Inc:
Cardiac Arrest
Pre-hospital
Mild hypothermia
Resuscitation

Additional relevant MeSH terms:
Heart Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014