Outcomes of Tracheostomy Decannulation: Study Protocol for a Longitudinal Observational Study

Tracheostomy management aims to achieve optimal decannulation outcomes in tracheostomized patients. Successful removal of the tracheal cannula (decannulation) is key from a physical and psychological health perspective. Decannulation success is commonly defined as the absence of physical complications leading to re-cannulation within a few hours or days post-decannulation. However, this definition does not account for complications occurring weeks or months later, or for (serious) complications that require actions other than re-cannulation. Additionally, the definition neglects the patients' experience of the decannulation outcome. This manuscript outlines the protocol of a study designed to comprehensively evaluate decannulation outcomes long-term, incorporating both physical and psychological variables.

This longitudinal, prospective, single-centre mixed-methods observational study entitled 'Outcomes of tracheostomy decannulation: A longitudinal observational study' aims to include a consecutive sample of 150 adult inpatients hospitalized in a large neurological rehabilitation centre specialized for spinal cord injury and prolonged weaning. Adult inpatients of various diagnoses who have undergone tracheostomy are eligible for inclusion if decannulation is sought and occurs in the study centre and if they are able to communicate in German, French, Italian, or English. Outcomes of interest include the rate and type of physical complications (occurring up to 3 months post-decannulation) and the consequences (e.g., intubation), the patients' view on benefits/harms of decannulation, and human flourishing pre- and post-decannulation. Candidate prognostic variables for complications post-decannulation are examined 1 week prior to decannulation and 1 month and 3 months post-decannulation. Data relating to the decannulation process, including decannulation criteria, will be recorded. Complication rates will be evaluated over 3 months post-decannulation using Kaplan-Meier and Nelson-Aalen estimators and time-to-event analysis. Decannulation-related complications will be descriptively analysed. Longitudinal changes in patient perspectives on decannulation outcomes are qualitatively and descriptively assessed, and the distribution across groups with and without complications is assessed.

A comprehensive understanding of physical and psychological decannulation outcomes will build the basis for optimized clinical decisions related to tracheostomy management and guide the development of an evidence-based clinical guideline for decannulation management.

ClinicalTrials.gov identifier: NCT06047665 WHAT THIS PAPER ADDS: What is already known on the subject Tracheostomy management is a multidisciplinary task and targets a timely and safe removal of the tracheal cannula (decannulation). Successful decannulation is key from a physical and psychological health perspective. Decannulation success is commonly defined as the absence of physical complications leading to re-cannulation within a few hours or days post-decannulation (short-term). What this paper adds to existing knowledge This study evaluates a variety of physical decannulation outcomes (including complications that do not result in a re-cannulation) for 3 months post-decannulation (long-term). Patients' perspective on decannulation outcomes are assessed as the views of those affected are key for a comprehensive assessment of decannulation outcomes. What are the potential or actual implications of this work? The data will build a foundation for optimized clinical decision-making related to decannulation management. The study will guide patient care pre- and post-decannulation to support positive long-term decannulation outcomes, reduce decannulation related medical and psychological sequalae, and contribute to economic decannulation management in relation to health care costs. This research will inform the development of an evidence-based clinical decannulation guideline.