An observational study in Silent Aspiration, Post-Extubation Dysphagia and Deglutition Disorders, sponsored by Cleveland Clinic Abu Dhabi. Not yet recruiting at 1 site in United Arab Emirates. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Cleveland Clinic Abu Dhabi · Observational
Post-extubation dysphagia is common in critically ill patients and may lead to silent aspiration, which often remains undetected because patients do not exhibit overt clinical signs such as coughing or choking. Current bedside nursing swallow screening may fail to identify silent aspiration in patients recovering from prolonged mechanical ventilation.
The goal of this observational study is to learn about the incidence, risk factors, and clinical outcomes of silent aspiration in critically ill adult patients who require prolonged mechanical ventilation and are extubated in the ICU. The main questions it aims to answer are:
Background:
Post-extubation dysphagia (PED) is common in critically ill patients and is often multifactorial in origin, resulting from trauma, neuromuscular weakness, altered sensation, impaired cognition, and desynchronized breathing-swallowing coordination. Silent aspiration - defined as entry of oropharyngeal material below the vocal folds without overt clinical signs such as coughing or choking - has been reported in up to 69.3% of ICU patients undergoing instrumental assessment. Despite this, current clinical practice at many centers does not mandate instrumental swallow evaluation for patients who pass routine bedside nursing swallow screening.
Study Design:
This is a prospective observational study conducted in the ICU at Cleveland Clinic Abu Dhabi (CCAD). Informed consent will be obtained from all patients or their next of kin prior to enrollment.
Participants:
Adult ICU patients who have been mechanically ventilated for 5 or more days and are subsequently extubated will be eligible for enrollment. Exclusion criteria include: (1) tracheostomy; (2) do-not-reintubate orders; (3) pregnancy; and (4) absence of informed consent.
Procedures:
All enrolled patients will undergo the standard bedside nursing swallow screen per institutional protocol (CCAD PolicyTech). For the purpose of this study, Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be performed in all enrolled patients up to 72 hours of extubation, regardless of bedside screening results. FEES is a well-established, safe, and portable instrumental assessment that allows direct visualization of pharyngeal and laryngeal structures and detection of aspiration, including silent aspiration. FEES will only be performed after approval by the treating attending physician, and patients with contraindications (e.g., high bleeding risk, high oxygen requirements) will be excluded from the procedure.
Assessments:
FEES findings will be reported using standardized validated scales including the Penetration-Aspiration Scale (PAS), Dysphagia Severity Rating Scale (DSRS), Pharyngeal Residue Severity Rating Scale (PRSS), Murray Secretion Scale, and Airway Protection Scale. Clinical data collected will include age, sex, admitting diagnosis, reasons for intubation, duration of mechanical ventilation, oxygen requirements, bedside swallow screen findings, and clinical outcomes including aspiration pneumonia, reintubation, ventilator-free days, ICU and hospital length of stay, and mortality.
Statistical Analysis:
Descriptive statistics will be used to report the incidence of silent aspiration. Diagnostic accuracy (sensitivity, specificity, Cohen's kappa) of bedside nursing screening will be calculated using FEES as the reference standard. Multivariable logistic regression will identify independent predictors of silent aspiration and its association with clinical outcomes. A minimum sample of 274 patients will be recruited (based on an expected 20% incidence, 95% CI, 5% margin of error, 10% loss to follow-up).
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 274 is above the median of 84 across 249 observational studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Cleveland Clinic Abu Dhabi is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Adult critically ill patients admitted to the ICU who require prolonged invasive mechanical ventilation (5 days or longer) and undergo extubation. Participants will undergo bedside swallow screening and FEES evaluation after extubation to assess for silent aspiration and post-extubation dysphagia.
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.
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult ICU patients intubated for 5 days or longer undergoing bedside swallow screening and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) within 72 hours after extubation to assess silent aspiration
Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
FEES will be performed within 72 hours after extubation to assess swallowing function and detect silent aspiration in ICU patients following prolonged mechanical ventilation.
Incidence of Silent Aspiration After Extubation
Silent aspiration identified by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in ICU patients intubated for 5 days or longer after extubation
Time frame: Up to 72 hours after extubation
Diagnostic Accuracy of Bedside Swallow Screening
Sensitivity and specificity of bedside nursing swallow screening for detecting silent aspiration using FEES as the reference standard
Time frame: Up to 72 hours after extubation
Aspiration Pneumonia
Incidence of aspiration pneumonia following extubation
Time frame: Up to 30 days after extubation
Reintubation
Need for reintubation after extubation
Time frame: Up to 30 days after extubation
Ventilator-Free Days
Number of ventilator-free days after extubation
Time frame: 28 days
ICU Length of Stay
Length of ICU stay after extubation
Time frame: Up to 24 weeks
Hospital length of stay
Total hospital length of stay
Time frame: Up to 26 weeks
ICU Mortality
Death occurring during ICU stay
Time frame: Up to 24 weeks
Hospital Mortality
Death occurring during hospitalization
Time frame: Up to 26 weeks
Risk Factors Associated With Silent Aspiration
Clinical factors independently associated with silent aspiration identified using multivariable analysis
Time frame: Up to 26 weeks
Duration of Dysphagia
Duration of post-extubation dysphagia identified by FEES
Time frame: Up to 3 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Cleveland Clinic Abu Dhabi