An observational study in Critical Illness, Mechanical Ventilation and Weaning Invasive Mechanical Ventilation, sponsored by Patricia Rodriguez Villamizar. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Patricia Rodriguez Villamizar · Observational
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:
Participants will:
Background
Recovery of consciousness following interruption of analgosedation is a critical step during liberation from invasive mechanical ventilation. Although Structured Awakening Evaluations (SAEs) are increasingly incorporated into routine intensive care practice, emergence from analgosedation remains highly heterogeneous and poorly characterized. Existing weaning classifications primarily focus on the duration and outcome of ventilator liberation but do not adequately characterize the transitional phase between analgosedation interruption and recovery of consciousness, despite this being a prerequisite for meaningful participation in the weaning process.
Early emergence from analgosedation may determine a patient's ability to participate in spontaneous breathing trials, achieve successful liberation from mechanical ventilation, develop delirium, and ultimately recover after critical illness. However, the trajectories of emergence during the first days following the first valid SAE and their relationship with clinically relevant outcomes remain largely unknown.
Study Objectives
The primary objective of AWAKE-ICU is to characterize early trajectories of emergence from analgosedation during the first 72 hours following the first valid Structured Awakening Evaluation (SAE) in mechanically ventilated critically ill adults.
Secondary objectives are to evaluate the association between early emergence trajectories and clinically relevant outcomes, including spontaneous breathing trial performance, successful liberation from mechanical ventilation, duration of mechanical ventilation, ventilator-free days, delirium, tracheostomy, ICU and hospital length of stay, mortality, and long-term functional, cognitive, and health-related quality-of-life outcomes up to one year.
Study Design
AWAKE-ICU is a prospective, multicenter, observational cohort study conducted in adult intensive care units. Consecutive eligible patients receiving invasive mechanical ventilation will undergo standardized serial assessments during the first 72 hours following their first valid SAE. Emergence from analgosedation will be evaluated using the Richmond Agitation-Sedation Scale (RASS) together with the ability to follow standardized motor commands, allowing classification into predefined trajectories of consciousness recovery.
Participants will be followed throughout their ICU and hospital stay and subsequently at 90 days and 12 months after ICU admission. By providing the first standardized characterization of emergence from analgosedation after a Structured Awakening Evaluation, AWAKE-ICU aims to improve understanding of this critical transition and to generate evidence supporting more individualized approaches to ventilator liberation and recovery after critical illness.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 500 is above the median of 194 across 342 observational studies indexed under Delirium.
Browse Delirium studies →This is the only study on the registry with Patricia Rodriguez Villamizar as lead sponsor.
Compared within Delirium, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
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:
Ongoing therapeutic sedation for neurological indications at the time of the first valid Structured Awakening Evaluation (SAE), including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult critically ill patients receiving invasive mechanical ventilation who undergo a first valid Structured Awakening Evaluation (SAE), defined according to the study protocol, following interruption or reduction of continuous analgosedation. Participants will undergo standardized serial assessments of emergence from analgosedation during the first 72 hours and will be followed throughout hospitalization and up to one year to evaluate clinical, functional and cognitive outcomes.
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.
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.
Time frame: At baseline (initiation of the index Structured Awakening Evaluation) and at 6, 12, 24, 48, and 72 hours after initiation of the index 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 frame: From initiation of the index Structured Awakening Evaluation through 24 hours, with assessments at baseline and at 6, 12, and 24 hours.
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.
Time frame: From initiation of the index SAE until the first extubation attempt, tracheostomy, death, ICU discharge, or Day 28 after the index SAE, whichever occurs first, assessed up to 28 days.
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.
Time frame: Day 28 after the first valid SAE.
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.
Time frame: Day 28 after the first valid SAE.
Intensive care unit length of stay
Number of days from admission to the intensive care unit to ICU discharge or death.
Time frame: From ICU admission through ICU discharge or death, assessed up to 12 months after ICU admission.
Hospital length of stay
Number of days from hospital admission to hospital discharge or death.
Time frame: From hospital admission through hospital discharge or death, assessed up to 12 months after ICU admission.
Intensive care unit mortality
Percentage of participants who die during the index ICU stay before ICU discharge.
Time frame: From ICU admission through ICU discharge or death, assessed up to 12 months after ICU admission.
In-hospital mortality
Percentage of participants who die during the index hospitalization before hospital discharge.
Time frame: From hospital admission until hospital discharge, assessed up to 12 months after ICU admission.
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.
Time frame: Assessed during the index Structured Awakening Evaluation, within 2 hours of SAE initiation.
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.
Time frame: From initiation of the index Structured Awakening Evaluation through 72 hours after initiation of the index SAE.
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.
Time frame: From completion of the index Structured Awakening Evaluation through ICU discharge, death, or 28 days after the index SAE, whichever occurs first.
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.
Time frame: From completion of the index Structured Awakening Evaluation through ICU discharge, death, or Day 28 after the index SAE, whichever occurs first.
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) index
The EQ-5D-5L index value will be derived from participants' responses across the five dimensions of the EuroQol 5-Dimension 5-Level questionnaire using the Spanish EQ-5D-5L value set. Index values range from -0.416 to 1, where 1 represents full health, 0 represents a health state equivalent to death, and negative values represent health states valued as worse than death. Higher index values indicate better health-related quality of life. The outcome will be assessed among participants with available follow-up data.
Time frame: At 90 days and 12 months after ICU admission.
Functional status assessed using the Barthel Index
Total Barthel Index score assessing independence in activities of daily living. Scores range from 0 to 100, with higher scores indicating greater functional independence. The outcome will be assessed among participants with available follow-up data.
Time frame: At 90 days and 12 months after ICU admission.
Living arrangement at follow-up
Percentage of participants in each prespecified living-arrangement category: home without support, home with support, nursing or residential care facility, hospital, or other setting. Each participant will be assigned to one category at each follow-up assessment.
Time frame: At 90 days and 12 months after ICU admission.
All-cause mortality at 90 days and 12 months
Percentage of participants who have died from any cause by each prespecified follow-up time point, among participants with available vital-status information.
Time frame: At 90 days and 12 months after ICU admission.
Symptoms of anxiety and depression assessed using the Patient Health Questionnaire-4 (PHQ-4)
Total score on the Patient Health Questionnaire-4 assessing symptoms of anxiety and depression. Total scores range from 0 to 12, with higher scores indicating greater psychological symptom burden and a worse mental health outcome. The outcome will be assessed among participants able to complete the questionnaire and with available follow-up data.
Time frame: At 90 days and 12 months after ICU admission.
Cognitive performance assessed using the Modified Telephone Interview for Cognitive Status (mTICS)
Total score on the Modified Telephone Interview for Cognitive Status obtained through direct structured telephone assessment. Scores range from 0 to 50, with higher scores indicating better cognitive performance. The outcome will be assessed among participants whose clinical, communicative, and cognitive condition permits a valid direct assessment and who have available follow-up data.
Time frame: At 90 days and 12 months after ICU admission.
Informant-reported cognitive decline assessed using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Mean item score on the Informant Questionnaire on Cognitive Decline in the Elderly, administered to a valid informant when a valid direct cognitive assessment using the mTICS cannot be completed. Mean scores range from 1 to 5, with higher scores indicating greater informant-reported cognitive decline and a worse cognitive outcome. The outcome will be assessed among participants with an available valid informant and follow-up data.
Time frame: At 90 days and 12 months after ICU admission.
Emergency department visits after hospital discharge
Number of emergency department visits occurring between hospital discharge and each prespecified follow-up assessment. Higher counts indicate greater healthcare resource utilization. The outcome will be assessed among participants with available follow-up information.
Time frame: Assessed at 90 days and 12 months after ICU admission, covering events from hospital discharge to each follow-up time point.
Hospital readmissions after hospital discharge
Number of unplanned or planned hospital readmissions occurring between hospital discharge and each prespecified follow-up assessment. Higher counts indicate greater healthcare resource utilization. The outcome will be assessed among participants with available follow-up information.
Time frame: Assessed at 90 days and 12 months after ICU admission, covering events from hospital discharge to each follow-up time point.
Intensive care unit readmissions after hospital discharge
Number of intensive care unit readmissions occurring between hospital discharge and each prespecified follow-up assessment. Higher counts indicate greater healthcare resource utilization. The outcome will be assessed among participants with available follow-up information.
Time frame: Assessed at 90 days and 12 months after ICU admission, covering events from hospital discharge to each follow-up time point.
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data underlying the published results will be made available upon reasonable request to the Principal Investigator after publication of the primary results, subject to approval of a research proposal, data use agreement, and compliance with applicable ethical and data protection regulations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Beginning 6 months after publication of the primary manuscript up to 5 years after publication
Access criteria: Reasonable scientific proposal approved by the steering committee and execution of a data-sharing agreement
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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