Critical Care Medicine, Critical Illness, Delirium, Mechanical Ventilation, Sedation and Analgesia, Weaning Invasive Mechanical Ventilation
Conditions
Keywords
Emergence from Analgosedation, Structured Awakening Evaluation, Recovery of Consciousness, Mechanical Ventilation, Richmond Agitation-Sedation Scale (RASS), Motor Command Assessment, Consciousness Trajectories, Mechanical Ventilation Weaning, Delayed Awakening
Brief 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.
Detailed description
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.
Interventions
PROCEDUREStructured 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.
Sponsors
Patricia Rodriguez Villamizar
Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trajectory of consciousness recovery during the first 72 hours following the first valid Structured Awakening Evaluation (SAE) | At baseline (initiation of the index Structured Awakening Evaluation) and at 6, 12, 24, 48, and 72 hours after initiation of the index 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early favorable recovery of consciousness | From initiation of the index Structured Awakening Evaluation through 24 hours, with assessments at baseline and at 6, 12, and 24 hours. | 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 | 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. | 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 | Day 28 after the first valid SAE. | 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 | Day 28 after the first valid SAE. | 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. |
| Intensive care unit length of stay | From ICU admission through ICU discharge or death, assessed up to 12 months after ICU admission. | Number of days from admission to the intensive care unit to ICU discharge or death. |
| Hospital length of stay | From hospital admission through hospital discharge or death, assessed up to 12 months after ICU admission. | Number of days from hospital admission to hospital discharge or death. |
| Intensive care unit mortality | From ICU admission through ICU discharge or death, assessed up to 12 months after ICU admission. | Percentage of participants who die during the index ICU stay before ICU discharge. |
| In-hospital mortality | From hospital admission until hospital discharge, assessed up to 12 months after ICU admission. | Percentage of participants who die during the index hospitalization before hospital discharge. |
Contacts
CONTACTPatricia Rodríguez Villamizar, MD, PhD
PRINCIPAL_INVESTIGATORPatricia Rodríguez Villamizar, MD, PhD
Hospital Universitario 12 de Octubre
Outcome results
None listed