Trans-Nasal Cooling Following Cardiac Arrest - Full Text View

Sponsored by:	BeneChill, Inc
Information provided by:	BeneChill, Inc
ClinicalTrials.gov Identifier:	NCT00808236

Purpose

The purpose of the study is to demonstrate the safety and feasibility of early trans-nasal cooling prior to ROSC in the EMS environment. It is hypothesized that cooling during the resuscitation attempt will increase ROSC and subseuquent survival.

Condition	Intervention
Cardiac Arrest	Device: RhinoChill

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study

Further study details as provided by BeneChill, Inc:

Primary Outcome Measures:

ROSC rate [ Time Frame: within 1 hour of arrest ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival to hospital discharge [ Time Frame: 30 days from arrest ] [ Designated as safety issue: No ]
24-hour SAE rate [ Time Frame: 24 hours after arrest ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	November 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Early Cooling	Device: RhinoChill Nasal catheters are placed and cooling is begun during the resuscitation attempt
2: No Intervention Standard of Care

Detailed Description:

Out of hospital cardiac arrest remains a significant cause of death. Mild hypothermia induced after resuscitation from caridac arrest has been shown to improve neurologically intact survial. Studies in rodents have demosntrated improved outcomes when cooling is initiated intra-arrest.

The RhinoChill Device is a non-invasive cooling device through which rapid cooling is achieved via the trans-nasal 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, cerebrovascular accident, 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 ROSC prior to initiating cooling
Are reached by EMS personnel more than 20 minutes after collapse

Contacts and Locations

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

Contacts

Contact: Becky Inderbitzen

858-695-8118 ext 216

binderbitzen@benechill.com

Locations

Belgium
CHU St Pierre	Recruiting
Brussels, Belgium, 1000
Contact: Diane DeLongueville diane@delongueville.net
Erasme Hospital (Free University of Brussels)	Recruiting
Brussels, Belgium, 1070
Contact: Fabio Taccone, Dr. med. ftaccone@ulb.ac.be
AZ St. Jan	Not yet recruiting
Brugge, Belgium, 8000
Contact: Patrick Martens, Dr. med. martens.patrick@scarlet.be
CHR de la Citadelle	Not yet recruiting
Liege, Belgium, 4000
Contact: Michel Vergnion
Helig Hartzieknehuis Roeselare	Not yet recruiting
Roeselare, Belgium, 8800
Contact: Pieterjan Durnez
AZ Groeninge	Not yet recruiting
Kortrijk, Belgium, 8500
Contact: Vincent Van Belleghem
UZ Gasthuisberg Leuven	Recruiting
Leuven, Belgium, B-3000
Contact: DIDIER DESRUELLES
CHU de Tivoli	Not yet recruiting
La Louviere, Belgium, 7100
Contact: Lambert Stamatakis
Czech Republic
Faculty Hospital Královské Vinohrady	Not yet recruiting
Prague, Czech Republic, 10034
Contact: Jan Pachl
Germany
Medizinisches Zentrum Kreis Aachen gGmbH	Recruiting
Aachen, Germany, 52146
Contact: Frank Eichwede, Dr. med. +49 (0) 2405 / 62-36 03 frank.eichwede@mz-ac.de
Albert Ludwigs University Freiburg	Recruiting
Freiburg, Germany, 79106
Contact: Hans-Joerg Busch, Dr. med. +49 (0) 761 270-3493 hans-joerg.busch@uniklinik-freiburg.de
Krankenhaus Martha-Maria Halle-Dölau gGmbH	Not yet recruiting
Halle (Saale), Germany, 06120
Contact: Harald Fritz, Priv.-Doz. Dr. med. habil. harald_fritz_2000@yahoo.de
HELIOS Klinikum Wuppertal	Not yet recruiting
Wuppertal, Germany, 42283
Contact: Gabriele Woebker gabriele.woebker@helios-kliniken.de
Italy
A.O Ospedale San Gerardo di Monza	Not yet recruiting
Monza, Italy, 20052
Contact: Antonio Pesenti

Sponsors and Collaborators

BeneChill, Inc

Investigators

Study Chair:

Denise Barbut, MD

BeneChill, Inc

More Information

Publications:

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. No abstract available.

Responsible Party:	BeneChill ( Becky Inderbitzen/Vice President Clinical Affairs )
Study ID Numbers:	BC-CP1012
Study First Received:	December 11, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00808236
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

Study placed in the following topic categories:

Hypothermia
Heart Diseases
Heart Arrest

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009