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Not yet recruitingNCT07659275APEXUpdated Jun 22, 2026

Swallowing Assessment for Predicting Extubation Failure in Critically Ill Patients

An observational study in Extubation Failure, Mechanical Ventilation and Critical Illness, sponsored by Universidade Federal de Pernambuco. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.

Sponsored by Universidade Federal de Pernambuco · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Extubation Failure
  • Mechanical Ventilation
  • Critical Illness

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03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's planned enrollment of 800 is above the median of 140 across 814 observational studies indexed under Critical Illness.

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Lead sponsor

Universidade Federal de Pernambuco is the lead sponsor of 166 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 from the patient or legally authorized representative, when required by local regulations.

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Extubation Failure

    Need for endotracheal reintubation after planned extubation.

    Time frame: Within 48 hours after extubation

07

Study locations

1 site
  • Hospital das Clínicas, Universidade Federal de Pernambuco
    Recife, Pernambuco, Brazil
    • Caio Morais · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07659275
Responsible party
Caio César Araújo Morais (PT, Universidade Federal de Pernambuco) — Principal investigator
First posted
Jun 22, 2026
Start date
Mar 30, 2027 (estimated)
Primary completion
Aug 30, 2030 (estimated)
Completion
Oct 30, 2030 (estimated)
Last update
Jun 22, 2026

Study contacts

Caio C. A. Morais, PhD
Contact
moraiscca@gmail.com
+55 81 996524096
Ana M Fontes, MSc
Contact
anamfontes@hotmail.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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