Clinical paperFeasibility and efficacy of a new non-invasive surface cooling device in post-resuscitation intensive care medicine☆
Introduction
Clinical studies have shown that patients treated with mild therapeutic hypothermia (33–34 °C) after cardiac arrest have improved neurological outcome and reduced mortality.1, 2, 3, 4 Maintaining mild hypothermia (33 °C) for 24 h after cardiac arrest became a standard therapy in post-resuscitation care.5, 6 In 2003, the advisory statement from the International Liaison Committee on Resuscitation (ILCOR) recommended therapeutic hypothermia after cardiac arrest. Recently, the European Resuscitation Council recommended mild hypothermia for unconscious adult patients with restoration of spontaneous circulation following out of hospital cardiac arrest due to ventricular fibrillation, and for the American Heart Association Advisory for CRR it is a class IIa recommendation.7, 8
Many different invasive and non-invasive cooling devices are currently available. More devices are also approaching the market. Our purpose was to show the safety, efficacy and clinical feasibility of a non-invasive surface cooling device (Arctic Sun, Medivance Incorporated, Louisville, CO, USA) to induce therapeutic hypothermia in humans after cardiac arrest. During this simple observational study Arctic Sun was not compared to other cooling methods, even if simultaneous studies of different methods were ongoing.
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Materials and methods
This was a prospective, observational case series with convenience sampling of comatose out of hospital cardiac arrest patients admitted to our emergency department between July 2004 and August 2005. The study procedures were in accordance with the ethical standards and approved by the responsible committee on human experimentation at the Medical University of Vienna. A waiver of consent was used for all patients. The patient's family was informed about the trial, and if there were any
Results
Out of 211 cardiac arrest patients admitted to our department 81 fulfilled the criteria for the application of mild therapeutic hypothermia; 28 (13%) were included in our study. The balance of patients eligible for cooling was enrolled in other hypothermia method trials, according to local allocation standards. Hypothermia was not started after inclusion in our study in one patient, who was resuscitated due to severe gastrointestinal bleeding and therefore did not match the inclusion criteria.
Discussion
In this simple observational study without comparison with both normal temperature controls and other established cooling devices we found the Arctic Sun System safe and effective in post-resuscitation intensive care medicine and satisfactory from a clinical use perspective.
In our trial we found a median time of 137 (96, 168) min for reaching target temperature after initiation of cooling with an average cooling rate of 1.4 ± 0.9 °C/h. Median time from restoration of spontaneous circulation to
Conclusion
Using the Arctic Sun System with Energy Transfer Pads in post-resuscitation care medicine for cooling cardiac arrest survivors is feasible and safe. The device has proven to be highly efficient in cooling these patients, provided stable maintenance of target temperature and allowed controlled active re-warming.
Conflict of interest
This work was supported by a grant of Medivance Incorporated, Louisville, CO, USA. Medivance Incorporated was not involved in the design of the study, data management, data analysis, or manuscript preparation or authorship. Medivance Incorporated was allowed to review the manuscript. However, any decisions regarding manuscript revision were made by the authors.
Acknowledgments
The Arctic Sun® and Arctic Sun Energy Transfer Pads™ were kindly provided by Medivance® Incorporated, Louisville, CO, USA.
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A Spanish translated version of the summary of this article appears as Appendix in the final online version at 10.1016/j.resuscitation.2007.03.001.