Extubation FailureAPEXNCT07659275
Swallowing Assessment for Predicting Extubation Failure in Critically Ill Patients
An observational study of Extubation Failure and Mechanical Ventilation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extubation Failure, Mechanical Ventilation, Critical Illness
- How many people
- 800 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Mar 2027to 30 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ana M Fontes, MSc contact
Brazil1 site
Hospital das Clínicas, Universidade Federal de Pernambuco
Recife, Pernambuco
Caio Morais
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation Failure
Need for endotracheal reintubation after planned extubation.
Measured: Within 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start30 Mar 2027 (estimated)
- Primary completion30 Aug 2030 (estimated)
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extubation FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caio César Araújo Morais, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659275
- Sponsor's protocol ID
- 7430216
- Acronym
- APEX
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Prognostic Performance of an Orotracheal Tube-Adapted Swallowing Biomechanics Assessment for Predicting Extubation Failure in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT07659275
- Acronym / sponsor ID
- APEX / 7430216
- Conditions
- Extubation Failure, Mechanical Ventilation, Critical Illness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 30 Mar 2027 (estimated)
- Primary completion
- 30 Aug 2030 (estimated)
- Study completion
- 30 Oct 2030 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extubation Failure
Time frame: Within 48 hours after extubation
Need for endotracheal reintubation after planned extubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana M Fontes, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extubation Failure and Mechanical Ventilation, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caio C. A. Morais, PhD (+55 81 996524096, moraiscca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation Failure (time frame: Within 48 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.