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    3 Committee considerations

    The evidence

    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 8 sources, which was discussed by the committee. The evidence included 2 systematic reviews and meta-analyses, 3 randomised controlled trials (RCTs), 1 registry analysis and 2 pilot RCTs. 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:

    • time to tracheostomy removal (decannulation)

    • degree of aspiration

    • change in dysphagia

    • the need for nasogastric and percutaneous endoscopic gastrostomy or jejunostomy feeding.

    3.3 The professional experts and the committee considered the key safety outcomes to be:

    • device-related discomfort or injury

    • degree of aspiration.

    3.4 Three telephone and 6 survey commentaries from people who have had this procedure were discussed by the committee.

    Committee comments

    3.5 The intensity of electrical stimulation applied is higher in more recent clinical practice and trials compared with earlier studies.

    3.6 There is a large ongoing RCT being done in people with stroke without a tracheostomy. This is due to complete in February 2025. There is an ongoing registry study in people with acute neurogenic dysphagia that is due to complete in December 2024.

    Tom Clutton-Brock
    Chair, interventional procedures advisory committee
    July 2023

    ISBN: