Clinical Trial

Swallowing Assessment for Predicting Extubation Failure in Critically Ill Patients

Study acronym: APEX
Not Yet Recruiting
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Summary
Extubation failure, defined as the need for reintubation after planned removal of the endotracheal tube, occurs in up to 20% of critically ill patients and is associated with prolonged mechanical ventilation, longer intensive care unit (ICU) stay, and increased mortality. Current assessments of extubation readiness focus primarily on respiratory performance and do not routinely evaluate upper airway protective function. The Airway Protection for Extubation (APEX) score is a bedside assessment tool based on swallowing biomechanics designed to evaluate airway protection before extubation. In a pilot prospective cohort study, the APEX score demonstrated promising performance for identifying patients at increased risk of extubation failure. This prospective multicenter cohort study will be conducted across ICUs in Brazil to externally validate the APEX score in critically ill adults undergoing planned extubation. The study will evaluate the discrimination, calibration, and clinical utility of the APEX score for predicting extubation failure and will assess its performance across different patient populations and hospital settings. The results of this study may support the incorporation of a simple bedside assessment of swallowing biomechanics into extubation readiness evaluation and contribute to more individualized decision-making regarding extubation in critically ill patients.
Trial Details
NCT Number NCT07659275
Lead Sponsor Universidade Federal de Pernambuco
Conditions Extubation Failure, Mechanical Ventilation, Critical Illness
Enrollment 800 participants
Start Date 2027-03-30
Primary Completion 2030-08-30 (estimated)
Study Completion 2030-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-22