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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Nasal catheters are placed and cooling is begun during the resuscitation attempt
Advanced cardiac life support according to American Heart Association \& European Resuscitation Council 2005 Guidelines
CHU St Pierre
Brussels, Belgium
Erasme Hospital (Free University of Brussels)
Brussels, Belgium
CHU de Tivoli
La Louvière, Belgium
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.
Time frame: 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.
Time frame: 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
Time frame: 30-days after arrest
Primary Outcomes in Sub-group With VF/VT as First Rhythm
ROSC, survival, and neurologically-intact survival
Time frame: 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.
Time frame: within 8 hours after enrollment
Length of Stay
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UZ Gasthuisberg Leuven
Leuven, Belgium
CHR de la Citadelle
Liège, Belgium
Helig Hartzieknehuis Roeselare
Roeselare, Belgium
Faculty Hospital Královské Vinohrady
Prague, Czechia
Medizinisches Zentrum Kreis Aachen gGmbH
Aachen, Germany
Charite Campus Virchow Klinikum
Berlin, Germany
Albert Ludwigs University Freiburg
Freiburg im Breisgau, Germany
...and 5 more locations
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after arrest