Intra-Arrest Transnasal Evaporative Cooling A Randomized, Prehospital, Multicenter Study (PRINCE: Pre-ROSC IntraNasal Cooling Effectiveness)

Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden.
Circulation (Impact Factor: 14.43). 08/2010; 122(7):729-36. DOI: 10.1161/CIRCULATIONAHA.109.931691
Source: PubMed


Transnasal evaporative cooling has sufficient heat transfer capacity for effective intra-arrest cooling and improves survival in swine. The aim of this study was to determine the safety, feasibility, and cooling efficacy of prehospital transnasal cooling in humans and to explore its effects on neurologically intact survival to hospital discharge.
Witnessed cardiac arrest patients with a treatment interval <or=20 minutes were randomized to intra-arrest cooling with a RhinoChill device (treatment group, n=96) versus standard care (control group, n=104). The final analysis included 93 versus 101 patients, respectively. Both groups were cooled after hospital arrival. The patients had similar demographics, initial rhythms, rates of bystander cardiopulmonary resuscitation, and intervals to cardiopulmonary resuscitation and arrival of advanced life support personnel. Eighteen device-related adverse events (1 periorbital emphysema, 3 epistaxis, 1 perioral bleed, and 13 nasal discolorations) were reported. Time to target temperature of 34 degrees C was shorter in the treatment group for both tympanic (102 versus 282 minutes, P=0.03) and core (155 versus 284 minutes, P=0.13) temperature. There were no significant differences in rates of return of spontaneous circulation between the groups (38% in treated subjects versus 43% in control subjects, P=0.48), in overall survival of those admitted alive (44% versus 31%, respectively, P=0.26), or in neurologically intact survival to discharge (Pittsburgh cerebral performance category scale 1 to 2, 34% versus 21%, P=0.21), although the study was not adequately powered to detect changes in these outcomes.
Prehospital intra-arrest transnasal cooling is safe and feasible and is associated with a significant improvement in the time intervals required to cool patients.

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Available from: Hans-Joerg Busch, Nov 12, 2015
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    • "Although no major adverse side effects were observed, a case of minor epistaxis occurred. Epistaxis was also reported at an incidence of 1.5% in the PRINCE trial investigating transnasal hypothermia (Castren et al., 2010). No cases of discoloration or sensitivity reactions of the epipharynx were reported. "
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    ABSTRACT: The safety, feasibility, and hemodynamic effects of mild hypothermia (MH) induced by transnasal cooling were studied in transcatheter aortic valve replacement (TAVR). MH is a common therapy following cardiac arrest and seems to have favorable effects in myocardial infarction and on hemodynamic stability. In TAVR, hemodynamic instability is common during rapid pacing. Twenty subjects undergoing TAVR were randomized 1:1 to hypothermia or normothermia. Hemodynamic endpoints were mean arterial blood pressure and required dosage of vasoactive and inotropic drugs. Patients were followed up at 6 months. All patients in the MH group (n=10) reached the target temperature of 34°C before first rapid pacing. Tympanic and urinary bladder temperature remained significantly lower in the MH group during the procedure. No adverse effects of cooling were observed. Mean arterial pressure was higher in the MH group (90±20 mm Hg) than in the control group (71±13 mm Hg) at the start of the procedure, at first rapid pacing (94±19 vs. 80±16 mm Hg), and at balloon aortic valvuloplasty (90±17 vs. 73±14 mm Hg). Less norepinephrine was administered to the hypothermia group. Transnasal cooling during TAVR was safe and well tolerated. We observed a more stable hemodynamic profile in the MH group, indicated by higher blood pressure and lower levels of vasoactive drugs required. A larger study of patients with severe ventricular dysfunction is required to more comprehensively investigate the hemodynamic effects of transnasal cooling in TAVR.
    Full-text · Article · Jul 2015
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    • "The device is a novel technology that uses two small cannula, inserted into a patient's nasal cavity, to deliver a spray of coolant mist that evaporates directly underneath the brain and the base of the skull. This cooling method can be started even before the return of blood circulation, and very shortly after the point of cardiac arrest [10, 19]. "
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    ABSTRACT: Therapeutic hypothermia is method used to improve the neurological status of patients who are at risk of ischaemia after myocardial infarction. We report a case of a 28-year-old woman who suffered acute myocardial infarction complicated by ventricular fibrillation. The patient was successfully resuscitated. Invasive and non-invasive medical treatment was applied including therapeutic hypothermia. Success was achieved due to adequate public reaction, fast transportation, blood vessel revascularization and application of therapeutic hypothermia. The patient was successfully discharged after one week of treatment, and just minor changes in heart function were present.
    Full-text · Article · Nov 2013 · Postepy w Kardiologii Interwencyjnej / Advances in Interventional Cardiology
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    • "Wolff et al. [23] studied rapidly cooled patients, using an endovascular device, and showed that the time to target temperature was an independent predictor of good outcome. Although underpowered, recent clinical trials of rapid cooling devices have shown trends towards survival benefit [24] and improvement in patient outcomes compared to historical controls [13]. Kory et al. [25] published a fast cooling method, using a combination of core and surface cooling modalities without the use of a commercial device, which resulted in a cooling rate of 2.6°C/h. "
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    ABSTRACT: INTRODUCTION: Mild therapeutic hypothermia (MTH) is a worldwide used therapy to improve neurological outcome in patients successfully resuscitated after cardiac arrest (CA). Preclinical data suggest that timing and speed of induction are related to reduction of secondary brain damage and improved outcome. METHODS: Aiming at a rapid induction and stable maintenance phase, MTH induced via continuous peritoneal lavage (PL) using Velomedix(R) Inc. automated PL system was evaluated and compared to historical controls in which hypothermia was achieved using cooled saline intravenous infusions and cooled blankets. RESULTS: In sixteen PL patients time to reach core target temperature of 32.5oC was 30 minutes (interquartile range [IQR]: 19-60), which was significantly faster compare to 150 minutes (IQR: 112-240) in controls. The median rate of cooling during the induction phase in the PL group of 4.1oC/hr (IQR: 2.2-8.2) was significantly faster compared to 0.9oC/hr (IQR: 0.5-1.3) in controls. During the 24 hours maintenance phase mean core temperature in the PL patients was 32.38+/-0.18oC (range: 32.03-32.69oC) and in control patients 32.46+/-0.48oC (range: 31.20-33.63oC), indicating more steady temperature control in the PL group compared to controls. Furthermore, the coefficient of variation (VC) for temperature during the maintenance phase was lower in the PL group (VC: 0.5%) compared to the control group (VC: 1.5%). In contrast to 23% of the control patients, none of the PL patients showed overshoot of hypothermia below 31oC during the maintenance phase. Survival and neurological outcome was not different between the two groups. Neither shivering nor complications related to insertion or use of the PL method were observed. CONCLUSIONS: Using PL in post CA patients results in rapidly reached target temperature and a very precise maintenance, unprecedented in clinical studies evaluating MTH techniques. This opens the way to investigate the effects on neurological outcome and survival of ultra-rapid cooling compared to standard cooling in controlled trials in various patient groups. Trial registration: ClinicalTrials.Gov NCT01016236.
    Full-text · Article · Feb 2013 · Critical care (London, England)
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