Potentially MOdifiable factors To ImproVe outcomes of mechanically Ventilated patients in a low-income country Intensive Care Units (MOTIVATE-ICU): rationale and protocol for a registry-embedded prospective observational study

Abstract

Objective: To identify modifiable intensive care unit factors associated with outcomes among patients receiving invasive mechanical ventilation in a low-income setting. Methods: This prospective, multicenter, registry-embedded observational study has two components: a prospective registry-based cohort assessing patient-and care-process-related factors and a cross-sectional intensive care unit survey evaluating organizational structure. Functional intensive care units in Uganda will be included. Patients aged ≥ 15 years old requiring invasive mechanical ventilation will be enrolled. Patients extubated within 48 hours, transferred after > 24 hours, and imminent early death will be excluded. Primary outcomes will include 28-day intensive care unit mortality, intensive care unit length of stay, and mechanical ventilation duration. Tracheostomy-related outcomes will be explored in a pre-planned sub-study. Factors potentially associated with outcomes will be categorized into non-modifiable and potentially modifiable factors. Non-modifiable factors will include patient-related factors like age, comorbidities, and illness severity; potentially modifiable factors include processes of care (e.g., sedation levels) and intensive care unit organizational structure (e.g., staffing patterns). Multilevel multivariable logistic regression models will assess association outcomes. Survival analysis (Kaplan-Meier curves) will explore mortality trends. Confounders will be identified using directed acyclic graphs. Results (anticipated findings): This study will generate high-quality data on modifiable intensive care unit factors associated with ventilated patient outcomes in low-resource settings. Conclusion: This is Uganda’s first registry-embedded, multicenter intensive care unit study to systematically potentially modifiable factors associated with ventilated patient outcomes. This study will provide evidence-based insights to optimize critical care management in low-and middle-income countries by leveraging real-time intensive care unit registry data.