Introduction: Tracheostomy is a common emergency procedure for critically ill patients to secure their airway. The speaking valve is a one-way ventilation valve that is attached to the end of the tracheostomy tube to help the patient remodel subglottic pressure. However, the efficacy and safety of speaking valves in adult patients with tracheostomy remain controversial. The purpose of this protocol is to describe and evaluate the effectiveness, safety and impact on the quality of life of speaking valves in adult patients with tracheostomy.

Methods And Analysis: We will search four English databases (PubMed, Embase, Cochrane Library and Web of Science), grey literature websites and reference lists of original studies to screen for studies that might meet the criteria. The two authors will independently screen the literature, extract data and assess the quality and risk of bias of the included studies. The primary outcomes will focus on the patients' swallowing function, vocalisation and quality of life. We will use a fixed effects model or a random effects model based on heterogeneity testing or a descriptive analysis only. The quality of evidence on the effects of interventions will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation.

Ethics And Dissemination: This study is based on the literature in the database and does not require the approval of the ethics committee. The results will be disseminated through a peer-reviewed journal and conferences.

Prospero Registration Number: CRD42024502906.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11284873PMC
http://dx.doi.org/10.1136/bmjopen-2024-086415DOI Listing

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