Pre-ROSC Intra-Nasal Cooling Effectiveness

NCT00808236 | Completed Results

• 1 other identifier: BC-CP1012
• Study Type: interventional
• Target: 200
• Locations: 5 countries
• Sites: 15

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.

Conditions

Cardiac Arrest

Keywords

Cardiac Arrest; Pre-hospital; Mild hypothermia; Resuscitation

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

RhinoChill

EXPERIMENTAL

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

Device: RhinoChill

Control

OTHER

Advanced cardiac life support, only

Other: Control

Interventions

RhinoChill DEVICE

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

Also known as: intra-nasal cooling

RhinoChill

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years
• Collapse was witnessed
• No pulse
• Unresponsive to external stimuli

You may not qualify if:

• 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

Sponsors & Collaborators

• BeneChill, Inc: lead

Study Sites (15)

CHU St Pierre

Brussels, 1000, Belgium

Location

Erasme Hospital (Free University of Brussels)

Brussels, 1070, Belgium

Location

CHU de Tivoli

La Louvière, 7100, Belgium

Location

UZ Gasthuisberg Leuven

Leuven, B-3000, Belgium

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

Helig Hartzieknehuis Roeselare

Roeselare, 8800, Belgium

Location

Faculty Hospital Královské Vinohrady

Prague, 10034, Czechia

Location

Medizinisches Zentrum Kreis Aachen gGmbH

Aachen, 52146, Germany

Location

Charite Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Albert Ludwigs University Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Georg August-Universität Göttingen

Göttingen, 37086, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, 06120, Germany

Location

Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120, Germany

Location

A.O Ospedale San Gerardo di Monza

Monza, 20052, Italy

Location

Stockholm Prehospital Centrum

Stockholm, 118 83, Sweden

Location

Related Publications (2)

• 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.

  PMID: 18482670 BACKGROUND

• 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.

  PMID: 20679548 DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Becky Inderbitzen, Vice President of Clincial Affairs
• Organization: BeneChill, Inc.

binderbitzen@benechill.com

858-695-8118

Study Officials

• Denise Barbut, MD

  BeneChill, Inc

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 15, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 10, 2011
• Results First Posted: July 16, 2010

Record last verified: 2011-06

Locations

BE (6); DE (6); CZ (1); SE (1); IT (1)