Pre-ROSC Intra-Nasal Cooling Effectiveness

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
RhinoChill	RhinoChill	Intra-arrest cooling with the RhinoChill during advanced cardiac life support
Control	Control	Advanced cardiac life support, only

Primary Outcome Measures

Name	Time	Method
Achieve Return of Spontaneous Circulation (ROSC)	1-hour after arrest	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	30 days after arrest	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	30-days after arrest	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

Secondary Outcome Measures

Name	Time	Method
Primary Outcomes in Sub-group With VF/VT as First Rhythm	hospital discharge	ROSC, survival, and neurologically-intact survival
Time to Therapeutic Temperature	within 8 hours after enrollment	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	Hospital Discharge	Length of stay data for patients admitted to the hospital will be calculated for: 1. Days on ventilator 2. Days in intensive care without ventilator 3. Days in general ward
Serious Adverse Events (SAEs)	7 days after arrest	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)	24 hours after arrest	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.

Locations (15): Faculty Hospital Královské Vinohrady
🇨🇿
Prague, Czech Republic
CHU de Tivoli
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La Louviere, Belgium
CHU St Pierre
🇧🇪
Brussels, Belgium
Erasme Hospital (Free University of Brussels)
🇧🇪
Brussels, Belgium
CHR de la Citadelle
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Liege, Belgium
UZ Gasthuisberg Leuven
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Leuven, Belgium
Medizinisches Zentrum Kreis Aachen gGmbH
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Aachen, Germany
Albert Ludwigs University Freiburg
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Freiburg, Germany
Charite Campus Virchow Klinikum
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Berlin, Germany
Helig Hartzieknehuis Roeselare
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Roeselare, Belgium
Georg August-Universität Göttingen
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Göttingen, Germany
Krankenhaus Martha-Maria Halle-Dölau gGmbH
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Halle (Saale), Germany
Otto-von-Guericke-Universität Magdeburg
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Magdeburg, Germany
Stockholm Prehospital Centrum
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Stockholm, Sweden
A.O Ospedale San Gerardo di Monza
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Monza, Italy