Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07659275

Swallowing Assessment for Predicting Extubation Failure in Critically Ill Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital das Clínicas, Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Location contact

Caio Morais

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Extubation Failure

    Time frame: Within 48 hours after extubation

    Need for endotracheal reintubation after planned extubation.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana M Fontes, MSc

CONTACT

[email protected]

Caio C. A. Morais, PhD

CONTACT

[email protected]

+55 81 996524096

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Acronym: APEX

Important dates

Study start
2027
Primary completion
2030
Study completion
2030
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.