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Clinical Trials in Brazil / NCT07659275
Starting soon Observational

Swallowing Assessment for Predicting Extubation Failure in Critically Ill Patients

NCT07659275 · tracked via the Priya Life Science Brazil tracker
Phase
Observational
Started
2027-03-30
Last updated
2026-06-22

Condition(s) studied

Extubation FailureMechanical VentilationCritical Illness

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years. * Admission to an intensive care unit. * Invasive mechanical ventilation for ≥48 hours. * Successful completion of a spontaneous breathing trial according to local practice. * Ability to undergo bedside swallowing biomechanics assessment using the APEX score before extubation. * Written informed consent from the patient or legally authorized representative, when required by local regulations. Exclusion Criteria: * Presence of a tracheostomy. * Decision to withhold or withdraw life-sustaining treatments. * Structural abnormalities of the upper airway or face precluding APEX assessment. * Conditions preventing assessment of swallowing biomechanics (e.g., maxillofacial trauma, recent head and neck surgery, or other conditions judged by the investigator to interfere with the evaluation).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital das Clínicas, Universidade Federal de Pernambuco Recife Pernambuco

More Universidade Federal de Pernambuco trials in Brazil

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07659275 on ClinicalTrials.gov ↗ ← All trials in Brazil