Global Predictors of Tracheostomy-Related Pressure Injury During COVID-19: Research Protocol

To determine the patient factors associated with tracheostomy-related pressure injury (TRPI) using a multilevel, multivariate logistic regression model and to evaluate how care during the COVID-19 pandemic affected TRPI and its predictors.

Secondary data analysis of a tracheostomy patient database and electronic medical records.

This secondary data analysis study will merge and analyze data from the Global Tracheostomy Collaborative and the electronic health records of a large US healthcare system. We will employ a multilevel logistic regression model to investigate the relationships between suspected risk factors for TRPI.

Given the impact of TRPI on patient outcomes and expenditures, it is imperative to standardize TRPI assessment, increase awareness of at-risk patient populations, and implement novel preventive modalities. This will be the first large-sample study quantifying the risk factors for TRPI and the impact of the COVID-19 pandemic.

This study aims to identify risk factors for TRPI, including the impact of the COVID-19 pandemic, using two large, diverse databases, thereby addressing a critical literature gap. The findings from this study will serve to direct future research in this under-researched adverse outcome of tracheostomy care.

The findings will inform the development of targeted interventions to mitigate the incidence and severity of TRPI, which will translate into improved patient outcomes and reduced healthcare expenditure.

The study protocol addresses the prevalence and risk factors of TRPI and examines the effects of the COVID-19 pandemic. The protocol details harmonizing two data sets of patients with a tracheostomy to provide a diverse global sample. This work serves as a reference for upcoming results manuscript publications and future protocol development.

This research protocol was reported using relevant components of the SPIRIT guidelines.

Patients, families, and healthcare professionals comprise the learning community of the Global Tracheostomy Collaborative. Patients and family members participate on the Board and inform practices for data usage.