Clinical Trial

Analysis of Weaning of Analgosedation and Kinetics of Emergence in Critically Ill Patients

Study acronym: AWAKE-ICU
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07710066
Lead Sponsor Patricia Rodriguez Villamizar
Collaborators: Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre
Conditions Critical Illness, Mechanical Ventilation, Weaning Invasive Mechanical Ventilation, Sedation and Analgesia, Critical Care Medicine, Delirium
Enrollment 500 participants
Start Date 2026-09-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-17