Physical Restraint Use in a US Intensive Care Setting Protocol for a retrospective cross-sectional analysis using the MIMIC-IV repository

Objective: To investigate disparities in physical restraint use in a U.S. intensive care unit (ICU) setting, focusing on the influence of demographic factors (ethnicity, sex, age), mental health diagnoses, intubation status, and ICU type. The study also examines trends before and after policy changes in 2014. Methods: This retrospective cross-sectional study uses MIMIC-IV data from adult ICU patients (2008 to 2022) at Beth Israel Deaconess Medical Center. The primary outcome is the proportion of ICU days with physical restraint. A multivariable Binomial Generalized Linear Model (GLM) with a logit link function, modeling the number of restraint days out of the total ICU days per patient, will estimate associations between patient factors and the daily likelihood of restraint. Results will be presented as adjusted odds ratios (aOR) with 95% confidence intervals. Temporal trends will be evaluated by comparing restraint use across predefined three year intervals. Secondary analyses include binary restraint use (yes/no), death in hospital within 24h of restrain utilisation (yes/no), interaction effects, and sensitivity analyses.