Simple swallow check may predict ventilator weaning failure
NCT ID NCT07659275
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a bedside tool called the APEX score, which evaluates swallowing biomechanics, to predict whether critically ill patients will need their breathing tube reinserted after planned removal. Researchers will enroll 800 adults on ventilators for at least 48 hours across multiple ICUs in Brazil. The goal is to see if adding this simple assessment to current checks can improve extubation decisions and reduce complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If the APEX score proves accurate, it could become a simple bedside tool to help doctors decide when it is safe to remove a breathing tube, potentially reducing complications.
- What could go wrong
- This is an observational study, not a treatment trial. The APEX score may not perform well across all patient groups or hospital settings, and it will not directly improve outcomes on its own.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2027
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult ICU patients undergoing planned extubation after at least 48 hours of invasive mechanical ventilation and successful completion of a spontaneous breathing trial.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital das Clínicas, Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
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