Swallowing Assessment for Predicting Extubation Failure in Critically Ill Patients (APEX)

June 15, 2026 updated by: Caio César Araújo Morais, Universidade Federal de Pernambuco

Prospective Evaluation of the Prognostic Performance of an Orotracheal Tube-Adapted Swallowing Biomechanics 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Hospital das Clínicas, Universidade Federal de Pernambuco
        • Contact:
          • Caio Morais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult ICU patients undergoing planned extubation after at least 48 hours of invasive mechanical ventilation and successful completion of a spontaneous breathing trial.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2027

Primary Completion (Estimated)

August 30, 2030

Study Completion (Estimated)

October 30, 2030

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7430216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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