Pre-ROSC Intra-Nasal Cooling Effectiveness (PRINCE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study|
- Achieve Return of Spontaneous Circulation (ROSC) [ Time Frame: 1-hour after arrest ] [ Designated as safety issue: No ]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.
- Survived to Hospital Discharge [ Time Frame: 30 days after arrest ] [ Designated as safety issue: No ]The study end-point was hospital discharge. This outcome measure is the patient count for those that were discharged alive from the hospital.
- Survived Neurologically-Intact [ Time Frame: 30-days after arrest ] [ Designated as safety issue: No ]
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
- Primary Outcomes in Sub-group With VF/VT as First Rhythm [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]ROSC, survival, and neurologically-intact survival
- Time to Therapeutic Temperature [ Time Frame: within 8 hours after enrollment ] [ Designated as safety issue: No ]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.
- Length of Stay [ Time Frame: Hospital Discharge ] [ Designated as safety issue: No ]
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
- Serious Adverse Events (SAEs) [ Time Frame: 7 days after arrest ] [ Designated as safety issue: Yes ]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.
- 24-hour Adverse Events (AE) [ Time Frame: 24 hours after arrest ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2008|
|Study Completion Date:||September 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Intra-arrest cooling with the RhinoChill during advanced cardiac life support
Nasal catheters are placed and cooling is begun during the resuscitation attempt
Other Name: intra-nasal cooling
Advanced cardiac life support, only
Advanced cardiac life support according to American Heart Association & European Resuscitation Council 2005 Guidelines
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808236
|CHU St Pierre|
|Brussels, Belgium, 1000|
|Erasme Hospital (Free University of Brussels)|
|Brussels, Belgium, 1070|
|CHU de Tivoli|
|La Louviere, Belgium, 7100|
|UZ Gasthuisberg Leuven|
|Leuven, Belgium, B-3000|
|CHR de la Citadelle|
|Liege, Belgium, 4000|
|Helig Hartzieknehuis Roeselare|
|Roeselare, Belgium, 8800|
|Faculty Hospital Královské Vinohrady|
|Prague, Czech Republic, 10034|
|Medizinisches Zentrum Kreis Aachen gGmbH|
|Aachen, Germany, 52146|
|Charite Campus Virchow Klinikum|
|Berlin, Germany, 13353|
|Albert Ludwigs University Freiburg|
|Freiburg, Germany, 79106|
|Georg August-Universität Göttingen|
|Göttingen, Germany, 37086|
|Krankenhaus Martha-Maria Halle-Dölau gGmbH|
|Halle (Saale), Germany, 06120|
|Magdeburg, Germany, 39120|
|A.O Ospedale San Gerardo di Monza|
|Monza, Italy, 20052|
|Stockholm Prehospital Centrum|
|Stockholm, Sweden, 118 83|
|Study Chair:||Denise Barbut, MD||BeneChill, Inc|