Pre-ROSC Intra-Nasal Cooling Effectiveness

NCT ID: NCT00808236

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-09-30

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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RhinoChill

Intra-arrest cooling with the RhinoChill during advanced cardiac life support

Group Type: EXPERIMENTAL

RhinoChill

Intervention Type: DEVICE

Nasal catheters are placed and cooling is begun during the resuscitation attempt

Control

Advanced cardiac life support, only

Group Type: OTHER

Control

Intervention Type: OTHER

Advanced cardiac life support according to American Heart Association \& European Resuscitation Council 2005 Guidelines

Interventions

RhinoChill

Nasal catheters are placed and cooling is begun during the resuscitation attempt

Intervention Type: DEVICE

Control

Advanced cardiac life support according to American Heart Association \& European Resuscitation Council 2005 Guidelines

Intervention Type: OTHER

Other Intervention Names

intra-nasal cooling

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeneChill, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

BeneChill

Principal Investigators

Denise Barbut, MD

Role: STUDY_CHAIR

BeneChill, Inc

Locations

CHU St Pierre

Brussels, , Belgium

Erasme Hospital (Free University of Brussels)

Brussels, , Belgium

CHU de Tivoli

La Louvière, , Belgium

UZ Gasthuisberg Leuven

Leuven, , Belgium

CHR de la Citadelle

Liège, , Belgium

Helig Hartzieknehuis Roeselare

Roeselare, , Belgium

Faculty Hospital Královské Vinohrady

Prague, , Czechia

Medizinisches Zentrum Kreis Aachen gGmbH

Aachen, , Germany

Charite Campus Virchow Klinikum

Berlin, , Germany

Albert Ludwigs University Freiburg

Freiburg im Breisgau, , Germany

Georg August-Universität Göttingen

Göttingen, , Germany

Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, , Germany

Otto-von-Guericke-Universität Magdeburg

Magdeburg, , Germany

A.O Ospedale San Gerardo di Monza

Monza, , Italy

Stockholm Prehospital Centrum

Stockholm, , Sweden

Countries

Belgium; Czechia; Germany; Italy; Sweden

References

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.

Reference Type: BACKGROUND

PMID: 18482670 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20679548 (View on PubMed)

Other Identifiers

BC-CP1012

Identifier Type: -

Identifier Source: org_study_id