Swallowing Assessment for Predicting Extubation Failure in Critically Ill Patients

Prospective Evaluation of the Prognostic Performance of an Orotracheal Tube-Adapted Swallowing Biomechanics Assessment for Predicting Extubation Failure in Critically Ill Patients

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07659275

Acronym

APEX

Enrollment

800

Registered

2026-06-22

Start date

2027-03-30

Completion date

2030-10-30

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Extubation Failure, Mechanical Ventilation

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Extubation Failure	Within 48 hours after extubation	Need for endotracheal reintubation after planned extubation.

Countries

Brazil

Contacts

CONTACTCaio C. A. Morais, PhD

moraiscca@gmail.com+55 81 996524096

CONTACTAna M Fontes, MSc

anamfontes@hotmail.com

Outcome results