Swallowing Assessment for Predicting Extubation Failure in Critically Ill Patients

NCT07659275 | Not Yet Recruiting

• 1 other identifier: 7430216
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Extubation Failure; Mechanical Ventilation; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Extubation Failure

  Need for endotracheal reintubation after planned extubation.

  Within 48 hours after extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Hospital das Clínicas, Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Caio C. A. Morais, PhD

CONTACT

+55 81 996524096; moraiscca@gmail.com

Ana M Fontes, MSc

CONTACT

anamfontes@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): March 30, 2027
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): October 30, 2030
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

BR (1)