Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07710066

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

Sponsor: Patricia Rodriguez Villamizar

View on ClinicalTrials.gov

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.

Official title: AWAKE-ICU: Analysis of Weaning of Analgosedation and Kinetics of Emergence in Critically Ill Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2026-09-01

Completion Date

2028-09-01

Last Updated

2026-07-17

Healthy Volunteers

Conditions

Critical Illness Mechanical Ventilation Weaning Invasive Mechanical Ventilation Sedation and Analgesia Critical Care Medicine Delirium

Interventions

PROCEDURE

Structured Awakening Evaluation (SAE)

A standardized clinical evaluation performed after interruption or reduction of continuous analgosedation according to the study protocol. The Structured Awakening Evaluation is part of routine clinical care and serves exclusively to define cohort entry and characterize emergence from analgosedation. No experimental intervention is assigned or administered as part of this observational study.

Inclusion Criteria: Adult critically ill patients with acute respiratory failure or requiring invasive mechanical ventilation in the context of critical illness will be consecutively enrolled. Eligible participants must meet all of the following criteria: * 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. * Provision of informed consent for participation in the study. Exclusion Criteria: 1. Acute primary structural brain injury in which the level of consciousness is primarily determined by the neurological condition or constitutes a therapeutic target, including but not limited to: * Moderate or severe traumatic brain injury. * Subarachnoid hemorrhage. * Ischemic or hemorrhagic stroke. * Central nervous system infections. * Other structural brain injuries requiring therapeutic sedation or goal-directed intensive neurological monitoring. 2. Ongoing therapeutic sedation for neurological indications at the time of the first valid Structured Awakening Evaluation (SAE), including: * Intracranial hypertension management. * Status epilepticus. * Other neuroprotective strategies requiring deep sedation. 3. ICU admission following cardiac arrest with return of spontaneous circulation and suspected hypoxic-ischemic brain injury or the need for targeted therapeutic sedation. 4. Insufficient clinical information to accurately identify the baseline time point (t0) and characterize the architecture of the first valid Structured Awakening Evaluation. 5. Patients receiving extracorporeal life support (ECLS/ECMO), in whom assessment of hemodynamic and respiratory stability before initiation of awakening and liberation from invasive mechanical ventilation is substantially more complex.