3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 7 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial, 3 non-randomised comparative studies and 3 case series. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: improved quality of life, reduction in disability and neurological injury.
3.3 The professional experts and the committee considered the key safety outcomes to be: mortality, cardiovascular complications, worsening neurological outcomes, shivering and infection.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that the evidence reviewed compared the use of special temperature modulation devices to achieve normothermia with conventional fever management, including antipyretic medications and standard cooling (such as surface cooling blankets).
3.6 The committee noted that the evidence reviewed showed many complications, but it was difficult to identify whether these were related to the neurological injury or the procedure.
3.7 The committee noted that there are various techniques used and that the safety profiles of the various techniques may be different.