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.
Consecutive adult critically ill patients receiving invasive mechanical ventilation for at least 24 hours who undergo a first valid Structured Awakening Evaluation (SAE) following continuous analgosedation during their ICU stay. The study focuses on patients without acute primary structural brain injury or active neuroprotective sedation, in whom recovery of consciousness, ventilator liberation, and subsequent clinical and patient-centered outcomes can be prospectively characterized.
Cohort
Prospective
Structured Awakening Evaluation (SAE)
Procedure/SurgeryA 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.
Trajectory of consciousness recovery during the first 72 hours following the first valid Structured Awakening Evaluation (SAE)
Distribution (%) of patients classified as State A, B, C or NI according to RASS and standardized command-following assessment at baseline, 6, 12, 24, 48 and 72 hours after the first valid SAE.
Early favorable recovery of consciousness
Percentage of participants achieving State A at any predefined assessment within the first 24 hours following the first valid Structured Awakening Evaluation (SAE). State A is defined as RASS ≥ -2 with correct performance of at least 3 of 4 standardized simple commands.
Time to first extubation attempt
Time in days from initiation of the index Structured Awakening Evaluation to the first removal of the endotracheal tube, excluding removal performed as part of tracheostomy.
Ventilator-free days at Day 28
Number of days alive and free from invasive mechanical ventilation during the first 28 days following the first valid Structured Awakening Evaluation (SAE). Participants who die before Day 28 or remain on invasive mechanical ventilation throughout the entire observation period will be assigned 0 ventilator-free days. In participants who undergo reintubation, only the days following the final extubation that is not followed by another reintubation within the 28-day observation period will be counted as ventilator-free days.
Delirium-free days at Day 28
Number of days during the first 28 days following the first valid Structured Awakening Evaluation (SAE) on which the participant is alive, remains in the intensive care unit, is evaluable for delirium, and has no delirium on the daily assessment. A participant will be considered evaluable for delirium when at least one valid assessment can be performed during that day with a Richmond Agitation-Sedation Scale (RASS) score ≥ -2. A delirium day will be defined as a day with at least one valid positive assessment using a validated delirium assessment tool, preferably the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Days on which delirium cannot be evaluated will not be counted as either delirium days or delirium-free days. Participants who die before Day 28 will not accumulate delirium-free days after death.
Tolerance of the index Structured Awakening Evaluation
Percentage of participants whose index Structured Awakening Evaluation (SAE) is completed and tolerated without early interruption or reversal because of clinically relevant instability, according to the predefined study criteria.
Intercurrent clinical factors during the first 72 hours after the index Structured Awakening Evaluation
Percentage of participants experiencing each prespecified intercurrent clinical factor during the first 72 hours after the index Structured Awakening Evaluation (SAE), including pain, agitation, patient-ventilator asynchrony, hemodynamic instability, respiratory deterioration, delirium, and changes in analgosedation. Participants may experience more than one intercurrent factor during the observation period.
Diagnostic testing prompted by delayed awakening
Percentage of participants who undergo at least one electroencephalogram (EEG) and/or neuroimaging study after the first valid Structured Awakening Evaluation (SAE) because of clinically documented delayed recovery of consciousness.
Clinically relevant findings on diagnostic testing for delayed awakening
Percentage of participants undergoing EEG and/or neuroimaging for delayed awakening in whom at least one clinically relevant finding is identified. Relevant EEG findings include epileptiform activity, status epilepticus, severe diffuse encephalopathy, or other clinically relevant patterns. Relevant neuroimaging findings include acute structural lesions, signs of hypoxic-ischemic injury, or other clinically relevant abnormalities.
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Patricia Rodriguez Villamizar
Lead sponsor
Hospital Universitario 12 de Octubre
Sponsor institution
Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre
Collaborator
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