Pre-ROSC Intra-Nasal Cooling Effectiveness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Trans-Nasal Cooling With the RhinoChill Device Following Cardiac Arrest: A Pilot Study

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: RhinoChill
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RhinoChill<br>Intra-arrest cooling with the RhinoChill during advanced cardiac life support | Device: RhinoChill<br>* Nasal catheters are placed and cooling is begun during the resuscitation attempt<br>* Other names: intra-nasal cooling;|
| Other: Control<br>Advanced cardiac life support, only | Other: Control<br>* Advanced cardiac life support according to American Heart Association & European Resuscitation Council 2005 Guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. - 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 | 30-days after arrest | 

Secondary Outcome Measures

| Outcome Measure | 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. | within 8 hours after enrollment | 
| Length of Stay | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Arrest, Pre-hospital, Mild hypothermia, Resuscitation