The goal of this prospective multicenter observational study is to characterize early trajectories of consciousness recovery following the first valid structured awakening trial in mechanically ventilated critically ill adults, a phase that is not captured by current weaning classifications.
The main questions it aims to answer are:
1. What trajectories of consciousness recovery occur during the first 72 hours after the first valid structured awakening trial? 2. Are different early consciousness trajectories associated with clinically relevant outcomes, including successful liberation from mechanical ventilation, delirium, duration of mechanical ventilation, ventilator-free days, mortality, and long-term functional and cognitive outcomes?
Participants will:
1. Undergo standardized serial assessments of consciousness during the first 72 hours after the first valid structured awakening trial using the Richmond Agitation-Sedation Scale (RASS) and a standardized motor command assessment. 2. Receive daily assessments for delirium and weaning-related outcomes during the ICU stay. 3. Be followed for clinical outcomes during hospitalization and for functional and cognitive recovery up to 1 year after ICU admission.
Age ≥18 years.
Receiving invasive mechanical ventilation for ≥24 hours.
Prior exposure to continuous analgosedation before undergoing a first valid Structured Awakening Evaluation (SAE) during the ICU stay, as defined by the study's operational criteria.
Availability of sufficient clinical information to identify the baseline time point (t0) and characterize the first valid Structured Awakening Evaluation according to the study's operational definitions.
Moderate or severe traumatic brain injury.
Subarachnoid hemorrhage.
Ischemic or hemorrhagic stroke.
Central nervous system infections.
Patricia Rodriguez Villamizar
Lead sponsor
Hospital Universitario 12 de Octubre
Sponsor institution
Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre
Collaborator