3.1 To inform the committee, 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 9 sources, which was discussed by the committee. The evidence included 1 systematic review, 3 randomised controlled trials (1 of which was a conference abstract and used for safety data only), 3 non-randomised comparative studies and 2 case series. It is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: reduction in mortality and stroke morbidity, and improved quality of life.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: worse neurological outcome, pneumonia and bleeding.
3.4 There are different methods and different devices used for the procedure.
3.5 There are variations in the degree of temperature control, both in the degree of cooling and the length of treatment period, and target temperatures can be difficult to achieve.
3.6 Pneumonia was more common in patients treated with this procedure.
3.7 This procedure should be differentiated from targeted temperature management more generally, which also includes treatment and prevention of pyrexia.