Pre-ROSC Intra-Nasal Cooling Effectiveness

Cardiac Arrest Clinical Trial

— PRINCE  

Official title:

Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808236
• Other study ID #: BC-CP1012
• Status: Completed
• Phase: N/A
• First received: December 11, 2008
• Last updated: June 8, 2011
• Start date: November 2008
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: BeneChill, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• RhinoChill
Nasal catheters are placed and cooling is begun during the resuscitation attempt

Other:
• Control
Advanced cardiac life support according to American Heart Association & European Resuscitation Council 2005 Guidelines

Locations

Country	Name	City	State
Belgium	CHU St Pierre	Brussels
Belgium	Erasme Hospital (Free University of Brussels)	Brussels
Belgium	CHU de Tivoli	La Louviere
Belgium	UZ Gasthuisberg Leuven	Leuven
Belgium	CHR de la Citadelle	Liege
Belgium	Helig Hartzieknehuis Roeselare	Roeselare
Czech Republic	Faculty Hospital Královské Vinohrady	Prague
Germany	Medizinisches Zentrum Kreis Aachen gGmbH	Aachen
Germany	Charite Campus Virchow Klinikum	Berlin
Germany	Albert Ludwigs University Freiburg	Freiburg
Germany	Georg August-Universität Göttingen	Göttingen
Germany	Krankenhaus Martha-Maria Halle-Dölau gGmbH	Halle (Saale)
Germany	Otto-von-Guericke-Universität Magdeburg	Magdeburg
Italy	A.O Ospedale San Gerardo di Monza	Monza
Sweden	Stockholm Prehospital Centrum	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
BeneChill, Inc

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany,  Italy,  Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Survived Neurologically-Intact	The Cerebral Performance Categories (CPC) are used to describe neurological outcome. A CPC of 1 or 2 is considered "neurologically intact."; - Good cerebral performance: little to no deficit.; - Moderate cerebral disability: capable of independent activities of daily life; - Severe cerebral disability: conscious, but dependent on others for daily support; - Coma or vegetative state; - Death or brain death	30-days after arrest	No
Secondary	Primary Outcomes in Sub-group With VF/VT as First Rhythm	ROSC, survival, and neurologically-intact survival	hospital discharge	No
Secondary	Time to Therapeutic Temperature	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.	within 8 hours after enrollment	No
Secondary	Length of Stay	Length of stay data for patients admitted to the hospital will be calculated for: Days on ventilator; Days in intensive care without ventilator; Days in general ward	Hospital Discharge	No
Secondary	Serious Adverse Events (SAEs)	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.	7 days after arrest	Yes
Secondary	24-hour Adverse Events (AE)	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.	24 hours after arrest	Yes