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Silent Aspiration Following Extubation in the ICU

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07635888
Acronym
SAFE-ICU
Enrollment
274
Registered
2026-06-09
Start date
2026-06-01
Completion date
2028-06-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Deglutition Disorders, Mechanical Ventilation Complication, Post-Extubation Dysphagia, Silent Aspiration

Keywords

Silent aspiration, ICU extubation, Post-extubation dysphagia, FEES, Fiberoptic Endoscopic Evaluation of Swallowing, Mechanical ventilation, Swallow screening, Aspiration pneumonia, Critical care, Dysphagia screening

Brief summary

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.

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).

Interventions

FEES will be performed within 72 hours after extubation to assess swallowing function and detect silent aspiration in ICU patients following prolonged mechanical ventilation.

Sponsors

Cleveland Clinic Abu Dhabi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Silent Aspiration After ExtubationUp to 72 hours after extubationSilent aspiration identified by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in ICU patients intubated for 5 days or longer after extubation

Secondary

MeasureTime frameDescription
Diagnostic Accuracy of Bedside Swallow ScreeningUp to 72 hours after extubationSensitivity and specificity of bedside nursing swallow screening for detecting silent aspiration using FEES as the reference standard
Aspiration PneumoniaUp to 30 days after extubationIncidence of aspiration pneumonia following extubation
ReintubationUp to 30 days after extubationNeed for reintubation after extubation
Ventilator-Free Days28 daysNumber of ventilator-free days after extubation
ICU Length of StayUp to 24 weeksLength of ICU stay after extubation
Hospital length of stayUp to 26 weeksTotal hospital length of stay
ICU MortalityUp to 24 weeksDeath occurring during ICU stay
Hospital MortalityUp to 26 weeksDeath occurring during hospitalization
Risk Factors Associated With Silent AspirationUp to 26 weeksClinical factors independently associated with silent aspiration identified using multivariable analysis
Duration of DysphagiaUp to 3 monthsDuration of post-extubation dysphagia identified by FEES

Countries

United Arab Emirates

Contacts

CONTACTJihad Mallat, MD, PhD
mallatj@ccad.ae+97125019000
PRINCIPAL_INVESTIGATORJihad Mallat, MD, PhD

Cleveland Clinic Abu Dhabi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026