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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RhinoChill | Experimental | Intra-arrest cooling with the RhinoChill during advanced cardiac life support |
|
| Control | Other | Advanced cardiac life support, only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RhinoChill | Device | Nasal catheters are placed and cooling is begun during the resuscitation attempt |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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."
| 30-days after arrest |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcomes in Sub-group With VF/VT as First Rhythm | ROSC, survival, and neurologically-intact survival | hospital discharge |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Barbut, MD | BeneChill, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU St Pierre | Brussels | 1000 | Belgium | |||
| Erasme Hospital (Free University of Brussels) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18482670 | Background | 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. | |
| 20679548 |
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Due to the emergency nature of the research, patients were often randomized into the study before all exclusion criteria could be ruled out (e.g., "Do Not Attempt to Resuscitate" (DNAR) orders, drug over-dose (OD), cerebrovascular accident (CVA)). Therefore, patients meeting pre-defined exclusion criteria were not included in the outcome measures.
Patients were recruited by emergency medical system advanced life support personnel over an 8-month period (November 2008 through June 2009). Patients appearing to meet the study criteria were randomized during ongoing resuscitation procedures. Patients that survived to hospital admission were followed until death or hospital discharge.
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| ID | Title | Description |
|---|---|---|
| FG000 | RhinoChill | Intra-arrest cooling with the RhinoChill during advanced cardiac life support |
| FG001 | Control | Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RhinoChill | Intra-arrest cooling with the RhinoChill during advanced cardiac life support |
| BG001 | Control | Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Overall number of participants included in analysis was 181: 82 RhinoChill patients and 99 Control patients |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only patients meeting all inclusion/exclusion criteria (IC/EC) were included in the analyses. 15 patients were found to not meet all IC/EC after enrollment. 2 more patients were lost to follow-up and 1 patient was crossed over (Control to RhinoChill) and then withdrawn. Informed consent nor data was obtained for any of these patients. | Posted | Number | participants | 1-hour after arrest |
|
Serious adverse events (SAEs) were collected over the first seven days after study enrollment. Other clinically significant adverse events were collected over the first 24 hours.
Death was not considered to be an SAE, but the result of one. Failure to achieve return of spontaneous circulation was not considered to be an SAE. Additional events that did not qualify for reporting as SAEs were re-arrests occurring within 24 hours and deaths directly due to lack of cardiac or neurological recovery from the index event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RhinoChill | Intra-arrest cooling with the RhinoChill during advanced cardiac life support |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarct | Cardiac disorders | Non-systematic Assessment | new; occurring more than 24 hours after hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Becky Inderbitzen, Vice President of Clincial Affairs | BeneChill, Inc. | 858-695-8118 | binderbitzen@benechill.com |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Control | Other | Advanced cardiac life support according to American Heart Association & European Resuscitation Council 2005 Guidelines |
|
| within 8 hours after enrollment |
| Length of Stay | Length of stay data for patients admitted to the hospital will be calculated for:
| Hospital Discharge |
| 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 |
| 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 |
| Brussels |
| 1070 |
| Belgium |
| CHU de Tivoli | La Louvière | 7100 | Belgium |
| UZ Gasthuisberg Leuven | Leuven | B-3000 | Belgium |
| CHR de la Citadelle | Liège | 4000 | Belgium |
| Helig Hartzieknehuis Roeselare | Roeselare | 8800 | Belgium |
| Faculty Hospital Královské Vinohrady | Prague | 10034 | Czechia |
| Medizinisches Zentrum Kreis Aachen gGmbH | Aachen | 52146 | Germany |
| Charite Campus Virchow Klinikum | Berlin | 13353 | Germany |
| Albert Ludwigs University Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Georg August-Universität Göttingen | Göttingen | 37086 | Germany |
| Krankenhaus Martha-Maria Halle-Dölau gGmbH | Halle | 06120 | Germany |
| Otto-von-Guericke-Universität Magdeburg | Magdeburg | 39120 | Germany |
| A.O Ospedale San Gerardo di Monza | Monza | 20052 | Italy |
| Stockholm Prehospital Centrum | Stockholm | 118 83 | Sweden |
| Derived |
| 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. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Death |
|
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Bystander CPR | The is the number of those participants that received bystander rescue cardiopulmonary resuscitation (CPR) efforts prior to the arrival of emergency medical service (EMS) personnel | Number | participants |
|
| Evaluable Participants | Eligible participants were those included in the analyses. These excluded those particiapnts found not meet all of the inclusion criteria or to have a pre-defined exclsion criteria as well as those lost to follow-up for whom no data was obtained. | Number | participants |
|
| First Rhythm | First rhythm was defined as ventricular fibrillation/non-perfusing ventricular tacchycardia (VF/VT), asystole, or pulseless electrical activity/electro-mechanical dissociation (PEA/EMD) | Number | participants |
|
| Elapsed time from collapse until: | Median | Inter-Quartile Range | minutes |
|
Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines. |
|
|
| 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. | The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn. One RhinoChill patient that achieved ROSC was found to be "DNAR" upon hospital arrival and was excluded from analyses thereafter. The final number of analyzed RhinoChill patients was therefore 82. | Posted | Number | participants | 30 days after arrest |
|
|
|
| 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."
| The set of patients excluding those not meeting IC/EC, not lost to follow-up, or not crossed-over/withdrawn. | Posted | Number | participants | 30-days after arrest |
|
|
|
| Secondary | Primary Outcomes in Sub-group With VF/VT as First Rhythm | ROSC, survival, and neurologically-intact survival | Subset of all included patients with VF/VT as the first cardiac rhythm present upon ECG assessment by EMS personnel | Posted | Number | participants | hospital discharge |
|
|
|
| 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. | The subset of patients that were resuscitated and subsequently received in-hospital cooling and reached the designated therapuetic temperatures. | Posted | Median | Inter-Quartile Range | minutes | within 8 hours after enrollment |
|
|
|
| Secondary | Length of Stay | Length of stay data for patients admitted to the hospital will be calculated for:
| Evaluable patients admitted to the hospital | Posted | Median | Inter-Quartile Range | days | Hospital Discharge |
|
|
|
| Post-Hoc | Primary Outcomes in Sub-group Receiving EMS CPR Within 10 Minutes of Collapse | ROSC, Survival, and neurologically-intact survival | Subset of patients receiving EMS CPR within 10 minutes of collapse (representing 75% of all patients) | Posted | Number | participants | Hospital discharge |
|
|
|
| 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. | All enrolled patients; see additional modified "at risk" population based on study attrition in the Adverse Event section. | Posted | Number | all participants | 7 days after arrest |
|
|
|
| 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. | all enrolled participants | Posted | Number | all participants | 24 hours after arrest |
|
|
|
| Post-Hoc | Outcomes for Patients Admitted to the Hospital | Suvival and neurologically intact survival | Subset of patients that achieved ROSC and were subsequently admitted to the hospital. | Posted | Number | participants | Hospital discharge |
|
|
|
| Post-Hoc | Outcomes for VF Patients Admitted to the Hospital | Survival and neurologically-intact survival for patients found in VF/VT admitted to the hospital | Subset of patients with an initial rhythm of VF/VT, achieved ROSC and were subsequently admitted to the hospital | Posted | Number | participants | Hospital discharge |
|
|
|
| Post-Hoc | Outcomes for Patients Receiving EMS CPR Within 10 Minutes of Collapse That Were Admitted to the Hospital | Subset of patients that received EMS CPR within 10 minutes of collapse, achieved ROSC, and were subsequently admitted to the hospital. | Posted | Number | participants | Hospital Discharge |
|
|
|
| 6 |
| 17 |
| 96 |
| EG001 | Control | Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines. | 12 | 3 | 104 |
|
| Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment | Bleeding could occur from any orifice |
|
| Convulsions | Nervous system disorders | Non-systematic Assessment |
|
| Lethal/long-lasting arrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Metabolic acidosis | General disorders | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Sepsis/Multi-organ failure | General disorders | Non-systematic Assessment |
|
| Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Nasal discoloration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Peri-orbital emphysema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| Survived Neurologically-Intact |
|
| Time to 33C Tympanic Temperature |
|
| Time to 33C Core Temperature |
|
| Survivors - ICU days (no ventilator) |
|
| Survivors - general ward days |
|
| Survived Neurologically-Intact |
|