NCT00808236|CompletedResults
Pre-ROSC Intra-Nasal Cooling Effectiveness
PRINCE
Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study
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PRINCE
Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study
Sponsor study identifier
interventional
200
5 countries
15
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
September 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 11, 2008
Actual (reported)December 15, 2008
Actual (reported)June 2009
Actual (reported)September 2009
Actual (reported)July 16, 2010
Actual (reported)Achieve Return of Spontaneous Circulation (ROSC)
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.
1-hour after arrest
Survived to Hospital Discharge
The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.
30 days after arrest
Survived Neurologically-Intact
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
30-days after arrest
Primary Outcomes in Sub-group With VF/VT as First Rhythm
hospital discharge
Time to Therapeutic Temperature
within 8 hours after enrollment
Length of Stay
Hospital Discharge
Serious Adverse Events (SAEs)
7 days after arrest
24-hour Adverse Events (AE)
24 hours after arrest
Intra-arrest cooling with the RhinoChill during advanced cardiac life support
Advanced cardiac life support, only
Nasal catheters are placed and cooling is begun during the resuscitation attempt
Advanced cardiac life support according to American Heart Association \& European Resuscitation Council 2005 Guidelines
CHU St Pierre
Brussels, 1000, Belgium
Erasme Hospital (Free University of Brussels)
Brussels, 1070, Belgium
CHU de Tivoli
La Louvière, 7100, Belgium
UZ Gasthuisberg Leuven
Leuven, B-3000, Belgium
CHR de la Citadelle
Liège, 4000, Belgium
Helig Hartzieknehuis Roeselare
Roeselare, 8800, Belgium
Faculty Hospital Královské Vinohrady
Prague, 10034, Czechia
Tsai MS, Barbut D, Tang W, Wang H, Guan J, Wang T, Sun S, Inderbitzen B, Weil MH. Rapid head cooling initiated coincident with cardiopulmonary resuscitation improves success of defibrillation and post-resuscitation myocardial function in a porcine model of prolonged cardiac arrest. J Am Coll Cardiol. 2008 May 20;51(20):1988-90. doi: 10.1016/j.jacc.2007.12.057. No abstract available.
Castren M, Nordberg P, Svensson L, Taccone F, Vincent JL, Desruelles D, Eichwede F, Mols P, Schwab T, Vergnion M, Storm C, Pesenti A, Pachl J, Guerisse F, Elste T, Roessler M, Fritz H, Durnez P, Busch HJ, Inderbitzen B, Barbut D. Intra-arrest transnasal evaporative cooling: a randomized, prehospital, multicenter study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness). Circulation. 2010 Aug 17;122(7):729-36. doi: 10.1161/CIRCULATIONAHA.109.931691. Epub 2010 Aug 2.
Denise Barbut, MD
BeneChill, Inc
200 participants (actual enrollment reported by the registry).
First Submitted
December 11, 2008
First Posted
December 15, 2008
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
The Strategies for Post Arrest Resuscitation and Care Network
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Medizinisches Zentrum Kreis Aachen gGmbH
Aachen, 52146, Germany
Charite Campus Virchow Klinikum
Berlin, 13353, Germany
Albert Ludwigs University Freiburg
Freiburg im Breisgau, 79106, Germany
Georg August-Universität Göttingen
Göttingen, 37086, Germany
Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, 06120, Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120, Germany
A.O Ospedale San Gerardo di Monza
Monza, 20052, Italy
Stockholm Prehospital Centrum
Stockholm, 118 83, Sweden
Primary Completion
June 2009
Actual (reported)Study Completion
September 2009
Actual (reported)Last Updated
June 10, 2011
Results First Posted
July 16, 2010
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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