Swallowing DisordersDISFEXNCT07734298
Ultrasound vs. Nasofibroscopy for Evaluating Dysphagia After Extubation in the ICU
A study testing Bedside Cervical Ultrasonography and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in people with Swallowing Disorders and Aspiration, run by Hospital H+ Queretaro at 1 site in Mexico.
Trial summary
The goal of this observational study is to evaluate the diagnostic performance and concordance of bedside cervical ultrasonography compared to Fiberoptic Endoscopic Evaluation of Swallowing (FEES) for the early detection of post-extubation dysphagia in critically ill adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swallowing Disorders, Aspiration
- What is being tested?
- Bedside Cervical Ultrasonography and Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 27 Jul 2026to 31 Aug 2026
- Phase
- Interventional
- 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
Who may be able to join
- Critically ill patients admitted to the Intensive Care Unit (ICU).
- Patients aged 18 years or older.
- Patients who have required orotracheal intubation and mechanical ventilation for a period exceeding 48 hours.
- Patients successfully liberated from mechanical ventilation (post-extubation phase).
- Obtainment of signed Informed Consent from the patient or their legal representative.
Who cannot join
- Patients with a known prior history of oropharyngeal dysphagia, esophageal disorders, or structural abnormalities of the upper airway.
- Patients with pre-existing neurological diseases that compromise the swallowing reflex (e.g., advanced Parkinson's disease, previous stroke with residual dysphagia, Amyotrophic Lateral Sclerosis).
- Patients with a history of head and neck surgery or radiotherapy.
- Patients with a Glasgow Coma Scale (GCS) score < 13 at the time of evaluation.
- Patients with hemodynamic instability or severe respiratory distress that precludes the diagnostic procedures.
- Anatomical limitations that prevent the correct placement of the ultrasound transducer or the introduction of the nasofibroscope (e.g., severe facial trauma, nasal obstruction).
- Medical contraindication for Fiberoptic Endoscopic Evaluation of Swallowing (FEES).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital H+
Querétaro City, Querétaro, 7600
About this study
Official title: Comparison Between Ultrasonographic and Nasofibroscopic Evaluation in Extubated Patients With Dysphagia in the Intensive Care Unit.
The goal of this observational study is to evaluate the diagnostic performance and concordance of bedside cervical ultrasonography compared to Fiberoptic Endoscopic Evaluation of Swallowing (FEES) for the early detection of post-extubation dysphagia in critically ill adult patients.
The main questions it aims to answer are:
- What is the degree of diagnostic concordance (Kappa index) between cervical ultrasonography and nasofibroscopy (FEES) for detecting dysphagia in the Intensive Care Unit (ICU)?
- What are the sensitivity, specificity, and predictive values of ultrasonography as a non-invasive screening tool compared to the gold standard (FEES)?
- Are there specific cut-off points for ultrasonographic parameters (such as hyoid bone displacement and laryngeal elevation) that accurately identify patients at risk of aspiration? Methodology and Comparison: Researchers will evaluate a cohort of patients who have undergone mechanical ventilation for more than 48 hours. The study compares the findings of cervical ultrasonography (an accessible and non-invasive bedside method) with FEES (the clinical gold standard) to determine the feasibility of ultrasound as an initial screening tool in the ICU setting. Participant Tasks: Participants will undergo the following procedures within 24 to 48 hours post-extubation: A bedside cervical ultrasonography to measure swallowing-related anatomical movements, such as hyoid displacement and laryngeal elevation. A nasofibroscopy (FEES) performed by trained personnel to directly visualize the pharyngeal and laryngeal structures during swallowing. A clinical evaluation of cranial nerve function and monitoring for respiratory complications like bronchoaspiration or pneumonia.
- Conditions
- Swallowing Disorders, Aspiration
- Being tested
- Bedside Cervical Ultrasonography, Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
- Keywords
- post-extubation dysphagia, Critical care ultrasonography, Swallowing disorders
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedside Cervical UltrasonographyDiagnostic test
Measurement of anatomical swallowing-related structures (hyoid bone and larynx) using a convex or linear transducer at the patient's bedside.
Fiberoptic Endoscopic Evaluation of Swallowing (FEES)Diagnostic test
Endoscopic visualization of the larynx and pharynx during the administration of various bolus consistencies to assess swallowing safety.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Evaluation Group | Experimental | This is a single-arm study where all participants who have been extubated after more than 48 hours of mechanical ventilation will undergo a sequential diagnostic assessment.
Each participant will receive:
* Cervical Ultrasonography: A non-invasive bedside evaluation to measure hyoid bone displacement and laryngeal elevation.
* Fiberoptic Endoscopic Evaluation of Swallowing (FEES): The gold standard endoscopic procedure to visualize the pharyngeal and laryngeal phases of swallowing and detect penetration or aspiration. Receives: Diagnostic Test: Bedside Cervical Ultrasonography; Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing (FEES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Concordance (Kappa Index).
The degree of diagnostic agreement between bedside cervical ultrasonography and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) for the detection of post-extubation dysphagia. This will be evaluated using Cohen's Kappa coefficient to determine if ultrasonography is a reliable alternative to the gold standard.
Measured: At 48 hours post-extubation.
Secondary outcomes (3)
Diagnostic Sensitivity and Specificity.
Calculation of the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cervical ultrasonography for detecting dysphagia, using FEES as the clinical reference standard.
Measured: At 48 hours post-extubation.
Ultrasonographic Parameter Cut-off Points.
Determination of optimal threshold values for ultrasonographic measurements, including hyoid bone displacement (mm) and laryngeal elevation, that correlate with the presence of dysphagia or aspiration.
Measured: At 48 hours post-extubation.
Incidence of Respiratory Complications.
Frequency of adverse events, specifically bronchoaspiration, the need for re-intubation, or the development of post-extubation pneumonia.
Measured: From ICU admission through ICU discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start27 Jul 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swallowing DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734298
- Sponsor's protocol ID
- CEI2026-04/02/V1
- Other IDs
- Hospital H +, Queretaro
- Acronym
- DISFEX
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasonographic and Nasofibroscopic Evaluation in Extubated Patients With Dysphagia in the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT07734298
- Acronym / sponsor ID
- DISFEX / CEI2026-04/02/V1
- Conditions
- Swallowing Disorders, Aspiration
- Keywords
- post-extubation dysphagia, Critical care ultrasonography, Swallowing disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 27 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 29 Jul 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.
The goal of this observational study is to evaluate the diagnostic performance and concordance of bedside cervical ultrasonography compared to Fiberoptic Endoscopic Evaluation of Swallowing (FEES) for the early detection of post-extubation dysphagia in critically ill adult patients.
The main questions it aims to answer are:
- What is the degree of diagnostic concordance (Kappa index) between cervical ultrasonography and nasofibroscopy (FEES) for detecting dysphagia in the Intensive Care Unit (ICU)?
- What are the sensitivity, specificity, and predictive values of ultrasonography as a non-invasive screening tool compared to the gold standard (FEES)?
- Are there specific cut-off points for ultrasonographic parameters (such as hyoid bone displacement and laryngeal elevation) that accurately identify patients at risk of aspiration? Methodology and Comparison: Researchers will evaluate a cohort of patients who have undergone mechanical ventilation for more than 48 hours. The study compares the findings of cervical ultrasonography (an accessible and non-invasive bedside method) with FEES (the clinical gold standard) to determine the feasibility of ultrasound as an initial screening tool in the ICU setting. Participant Tasks: Participants will undergo the following procedures within 24 to 48 hours post-extubation: A bedside cervical ultrasonography to measure swallowing-related anatomical movements, such as hyoid displacement and laryngeal elevation. A nasofibroscopy (FEES) performed by trained personnel to directly visualize the pharyngeal and laryngeal structures during swallowing. A clinical evaluation of cranial nerve function and monitoring for respiratory complications like bronchoaspiration or pneumonia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Evaluation Group | Experimental | Diagnostic Test: Bedside Cervical Ultrasonography, Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)This is a single-arm study where all participants who have been extubated after more than 48 hours of mechanical ventilation will undergo a sequential diagnostic assessment. Each participant will receive: * Cervical Ultrasonography: A non-invasive bedside evaluation to measure hyoid bone displacement and laryngeal elevation. * Fiberoptic Endoscopic Evaluation of Swallowing (FEES): The gold standard endoscopic procedure to visualize the pharyngeal and laryngeal phases of swallowing and detect penetration or aspiration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Critically ill patients admitted to the Intensive Care Unit (ICU).
- Patients aged 18 years or older.
- Patients who have required orotracheal intubation and mechanical ventilation for a period exceeding 48 hours.
- Patients successfully liberated from mechanical ventilation (post-extubation phase).
- Obtainment of signed Informed Consent from the patient or their legal representative.
Key exclusion criteria (7 listed)
- Patients with a known prior history of oropharyngeal dysphagia, esophageal disorders, or structural abnormalities of the upper airway.
- Patients with pre-existing neurological diseases that compromise the swallowing reflex (e.g., advanced Parkinson's disease, previous stroke with residual dysphagia, Amyotrophic Lateral Sclerosis).
- Patients with a history of head and neck surgery or radiotherapy.
- Patients with a Glasgow Coma Scale (GCS) score < 13 at the time of evaluation.
- Patients with hemodynamic instability or severe respiratory distress that precludes the diagnostic procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedside Cervical UltrasonographyMeasurement of anatomical swallowing-related structures (hyoid bone and larynx) using a convex or linear transducer at the patient's bedside. | Diagnostic test | Diagnostic Evaluation Group |
| Fiberoptic Endoscopic Evaluation of Swallowing (FEES)Endoscopic visualization of the larynx and pharynx during the administration of various bolus consistencies to assess swallowing safety. | Diagnostic test | Diagnostic Evaluation Group |
Primary outcome
Diagnostic Concordance (Kappa Index).
Time frame: At 48 hours post-extubation.
The degree of diagnostic agreement between bedside cervical ultrasonography and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) for the detection of post-extubation dysphagia. This will be evaluated using Cohen's Kappa coefficient to determine if ultrasonography is a reliable alternative to the gold standard.
3 secondary outcomes
Diagnostic Sensitivity and Specificity.
Time frame: At 48 hours post-extubation.
Ultrasonographic Parameter Cut-off Points.
Time frame: At 48 hours post-extubation.
Incidence of Respiratory Complications.
Time frame: From ICU admission through ICU discharge, up to 30 days
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 29 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedside Cervical Ultrasonography and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in people with Swallowing Disorders and Aspiration, run by Hospital H+ Queretaro at 1 site in Mexico.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Jul 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 Mexico. 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 Amy Sevilla Valle (+505-8557-2609, sevillavalleamy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Concordance (Kappa Index). (time frame: At 48 hours post-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 29 Jul 2026.