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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICU Patients Following Prolonged Mechanical Ventilation | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiberoptic Endoscopic Evaluation of Swallowing (FEES) | Diagnostic Test | FEES will be performed within 72 hours after extubation to assess swallowing function and detect silent aspiration in ICU patients following prolonged mechanical ventilation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 72 hours after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of Bedside Swallow Screening | Sensitivity and specificity of bedside nursing swallow screening for detecting silent aspiration using FEES as the reference standard | Up to 72 hours after extubation |
| Aspiration Pneumonia |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihad Mallat, MD, PhD | Contact | +97125019000 | mallatj@ccad.ae |
| Name | Affiliation | Role |
|---|---|---|
| Jihad Mallat, MD, PhD | Cleveland Clinic Abu Dhabi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Abu Dhabi | Abu Dhabi | United Arab Emirates |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D016638 | Critical Illness |
| D011015 | Pneumonia, Aspiration |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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Incidence of aspiration pneumonia following extubation
| Up to 30 days after extubation |
| Reintubation | Need for reintubation after extubation | Up to 30 days after extubation |
| Ventilator-Free Days | Number of ventilator-free days after extubation | 28 days |
| ICU Length of Stay | Length of ICU stay after extubation | Up to 24 weeks |
| Hospital length of stay | Total hospital length of stay | Up to 26 weeks |
| ICU Mortality | Death occurring during ICU stay | Up to 24 weeks |
| Hospital Mortality | Death occurring during hospitalization | Up to 26 weeks |
| Risk Factors Associated With Silent Aspiration | Clinical factors independently associated with silent aspiration identified using multivariable analysis | Up to 26 weeks |
| Duration of Dysphagia | Duration of post-extubation dysphagia identified by FEES | Up to 3 months |
| D010038 | Otorhinolaryngologic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |