Safety of early mobilisation in the intensive care unit: a prospective and multicentre cohort study protocol

Intensive care unit-acquired weakness (ICU-AW) is a common complication in critically ill patients, with an incidence of approximately 50% in the ICU. It is closely associated with increased morbidity, physical deterioration and higher short-term and long-term mortality. Its main characteristics include generalised and symmetrical muscle weakness affecting both respiratory and limb muscles. Early mobilisation has been identified as a feasible intervention in critically ill patients to mitigate the effects of ICU-AW. However, the incidence and nature of potential adverse events associated with its implementation are not yet well established. Therefore, this study aims to evaluate the safety outcomes in a cohort of patients undergoing early mobilisation in the ICU.

This is a prospective, multicentre, observational cohort study that will be conducted between June and December 2025 in four high-complexity ICUs in Bogotá, Colombia. The study will enrol 135 consecutive adult patients (≥18 years) admitted to the ICU who meet the eligibility criteria. Recruitment will follow a non-probabilistic, consecutive sampling approach in which all eligible patients will be included as they are admitted.At least 900 early mobilisation sessions are expected. Baseline sociodemographic and clinical data will be collected, and each session will be documented using a standardised form.The primary outcome is the occurrence of adverse events during early mobilisation sessions. These events will be classified as serious or non-serious and assessed by an independent committee to determine causality and preventability.Secondary outcomes include the total number of mobilisation sessions per patient and the highest level of mobility achieved, assessed using the ICU Mobility Scale (IMS).The analysis will include descriptive statistics, incidence of adverse events, session counts and IMS scores. A subgroup analysis will be conducted based on vasopressor use and dosage to explore potential differences in mobility outcomes.

Ethical approval has been obtained from the Fundación Universitaria Sanitas Research Ethics Committee (CEIFUS 1347-24) Clinical Trials Registration number NCT06653998. The findings will be disseminated in clinical trials study profile, in peer-reviewed journals and presentations at conferences.

NCT06653998.