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NCT Number: NCT07635888

Silent Aspiration Following 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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Silent Aspiration After Extubation

    Time frame: Up to 72 hours after extubation

    Silent aspiration identified by Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in ICU patients intubated for 5 days or longer after extubation

Secondary outcomes

  1. Diagnostic Accuracy of Bedside Swallow Screening

    Time frame: Up to 72 hours after extubation

    Sensitivity and specificity of bedside nursing swallow screening for detecting silent aspiration using FEES as the reference standard

  2. Aspiration Pneumonia

    Time frame: Up to 30 days after extubation

    Incidence of aspiration pneumonia following extubation

  3. Reintubation

    Time frame: Up to 30 days after extubation

    Need for reintubation after extubation

  4. Ventilator-Free Days

    Time frame: 28 days

    Number of ventilator-free days after extubation

  5. ICU Length of Stay

    Time frame: Up to 24 weeks

    Length of ICU stay after extubation

  6. Hospital length of stay

    Time frame: Up to 26 weeks

    Total hospital length of stay

  7. ICU Mortality

    Time frame: Up to 24 weeks

    Death occurring during ICU stay

  8. Hospital Mortality

    Time frame: Up to 26 weeks

    Death occurring during hospitalization

  9. Risk Factors Associated With Silent Aspiration

    Time frame: Up to 26 weeks

    Clinical factors independently associated with silent aspiration identified using multivariable analysis

  10. Duration of Dysphagia

    Time frame: Up to 3 months

    Duration of post-extubation dysphagia identified by FEES

Study contacts

Contact information is provided by the study sponsor or research team.

Jihad Mallat, MD, PhD

CONTACT

[email protected]

+97125019000

Sponsors and collaborators

Lead sponsor

Cleveland Clinic Abu Dhabi

Other

Registry information

Official study title

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

Acronym: SAFE-ICU

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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