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

Sponsor
Patricia Rodriguez Villamizar
Study ID
NCT07710066
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Structured Awakening Evaluation (SAE) — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Mechanically Ventilated Critically Ill Adults
    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.

Primary Outcome Measure

Trajectory of consciousness recovery during the first 72 hours following the first valid Structured Awakening Evaluation (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. ]

Central Contacts

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