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

NCT07710066 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-07-17

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre

    collaborator UNKNOWN

  • Patricia Rodriguez Villamizar

    lead OTHER

Principal Investigators

  • Patricia Rodríguez Villamizar, MD, PhD · Hospital Universitario 12 de Octubre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2028-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07710066 on ClinicalTrials.gov