Silent Aspiration Following Extubation in the ICU (SAFE-ICU)

Incidence, Risk Factors, and Outcomes of Silent Aspiration Post Extubation in the ICU

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:

• How often does silent aspiration occur in ICU patients intubated for 5 days or longer after extubation?
• Can silent aspiration be present despite passing the routine bedside nursing swallow screen?
• What clinical factors are associated with silent aspiration?
• Is silent aspiration associated with worse clinical outcomes such as aspiration pneumonia, reintubation, prolonged ICU stay, ventilator-free days, or mortality? Participants who have been mechanically ventilated for 5 days or more will undergo routine bedside swallow screening followed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES), considered the gold-standard diagnostic tool for detecting silent aspiration, within 72 hours after extubation. Researchers will compare bedside nursing swallow screening results with FEES findings to evaluate the diagnostic accuracy of bedside screening in detecting silent aspiration. Clinical data, swallowing assessment findings, and patient outcomes will also be collected and analyzed.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Deglutition Disorders; Mechanical Ventilation Complication; Silent Aspiration; Post-Extubation Dysphagia
• Intervention / Treatment: Diagnostic test: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 274

Contacts and Locations

• Study Contact: Name: Jihad Mallat, MD, PhD; Phone Number: +97125019000; Email: mallatj@ccad.ae

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Cleveland Clinic Abu Dhabi
    • Contact: Jihad Mallat, MD PhD; Phone Number: +97125019000; Email: mallatj@ccad.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Adult ICU patients requiring invasive mechanical ventilation for 5 days or longer
• Successful extubation after invasive mechanical ventilation
• Undergoing bedside nursing swallow screening after extubation
• Ability to undergo Fiberoptic Endoscopic Evaluation of Swallowing (FEES) within 72 hours after extubation
• Provision of informed consent by the patient or legally authorized representative

Exclusion Criteria:

• Presence of tracheostomy
• Do-not-reintubate orders/Allow natural death
• Pregnancy
• Absence of informed consent
• Contraindication to FEES as determined by the treating physician (e.g., high bleeding risk or severe oxygen requirements)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Cleveland Clinic Abu Dhabi
• Investigators: Principal Investigator: Jihad Mallat, MD, PhD, Cleveland Clinic Abu Dhabi

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Critical care; Mechanical ventilation; FEES; Dysphagia screening; Aspiration pneumonia; Swallow screening; Fiberoptic Endoscopic Evaluation of Swallowing; Silent aspiration; ICU extubation; Post-extubation dysphagia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Esophageal Diseases; Pneumonia; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Pathological Conditions, Signs and Symptoms; Critical Illness; Deglutition Disorders; Pneumonia, Aspiration
• Other Study ID Numbers: A-2026-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No