Clinical trial NCT00808236: Pre-ROSC Intra-Nasal Cooling Effectiveness
Official title: Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: Cardiac Arrest
Pre-hospital
Mild hypothermia
Resuscitation
Lead sponsor: BeneChill, Inc
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Achieve Return of Spontaneous Circulation (ROSC)
timeFrame: 1-hour after arrest
measure: Survived to Hospital Discharge
timeFrame: 30 days after arrest
measure: Survived Neurologically-Intact
timeFrame: 30-days after arrest
Secondary outcomes:
measure: Primary Outcomes in Sub-group With VF/VT as First Rhythm
timeFrame: hospital discharge
measure: Time to Therapeutic Temperature
timeFrame: within 8 hours after enrollment
measure: Length of Stay
timeFrame: Hospital Discharge
measure: Serious Adverse Events (SAEs)
timeFrame: 7 days after arrest
measure: 24-hour Adverse Events (AE)
timeFrame: 24 hours after arrest
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
city: Brussels
country: Belgium
facility: Erasme Hospital (Free University of Brussels)
city: La Louviere
country: Belgium
facility: CHU de Tivoli
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven
city: Liege
country: Belgium
facility: CHR de la Citadelle
city: Roeselare
country: Belgium
facility: Helig Hartzieknehuis Roeselare
city: Prague
country: Czech Republic
facility: Faculty Hospital Královské Vinohrady
city: Aachen
country: Germany
facility: Medizinisches Zentrum Kreis Aachen gGmbH
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum
city: Freiburg
country: Germany
facility: Albert Ludwigs University Freiburg
city: Göttingen
country: Germany
facility: Georg August-Universität Göttingen
city: Halle (Saale)
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau gGmbH
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
city: Monza
country: Italy
facility: A.O Ospedale San Gerardo di Monza
city: Stockholm
country: Sweden
facility: Stockholm Prehospital Centrum
Study officials:
affiliation: BeneChill, Inc
name: Denise Barbut, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.