AWAKE-ICU: Analysis of Weaning of Analgosedation and Kinetics of Emergence in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Trajectory of consciousness recovery during the first 72 hours following the first valid Structured Awakening Evaluation (SAE)
研究概览
简要总结
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:
- What trajectories of consciousness recovery occur during the first 72 hours after the first valid structured awakening trial?
- 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:
- 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.
- Receive daily assessments for delirium and weaning-related outcomes during the ICU stay.
- Be followed for clinical outcomes during hospitalization and for functional and cognitive recovery up to 1 year after ICU admission.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
- •ICU admission following cardiac arrest with return of spontaneous circulation and suspected hypoxic-ischemic brain injury or the need for targeted therapeutic sedation.
- •Insufficient clinical information to accurately identify the baseline time point (t0) and characterize the architecture of the first valid Structured Awakening Evaluation.
- •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.
结局指标
主要结局
Trajectory of consciousness recovery during the first 72 hours following the first valid Structured Awakening Evaluation (SAE)
时间窗: 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.
次要结局
- 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.)
- 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.)
- Ventilator-free days at Day 28(Day 28 after the first valid SAE.)
- Delirium-free days at Day 28(Day 28 after the first valid SAE.)
- Intensive care unit length of stay(From ICU admission through ICU discharge or death, assessed up to 12 months after ICU admission.)
- Hospital length of stay(From hospital admission through hospital discharge or death, assessed up to 12 months after ICU admission.)
- Intensive care unit mortality(From ICU admission through ICU discharge or death, assessed up to 12 months after ICU admission.)
- In-hospital mortality(From hospital admission until hospital discharge, assessed up to 12 months after ICU admission.)
研究者
Patricia Rodriguez Villamizar
Intensivist and Clinical Researcher
Hospital Universitario 12 de Octubre