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Not yet recruitingNCT07635888SAFE-ICUUpdated Jun 9, 2026

Silent Aspiration Following Extubation in the ICU

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
274
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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).

02

Conditions studied

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

Keywords

  • Silent aspiration
  • ICU extubation
  • Post-extubation dysphagia
  • FEES
  • Fiberoptic Endoscopic Evaluation of Swallowing
  • Mechanical ventilation
  • Swallow screening
  • Aspiration pneumonia
  • Critical care
  • Dysphagia screening
03

In context

Deglutition Disorders

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 →

Lead sponsor

Cleveland Clinic Abu Dhabi is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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.

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 by the patient or legally authorized representative

Exclusion criteria

Exclusion Criteria:

  • Presence of tracheostomy
  • Do-not-reintubate orders/Allow natural death
  • Pregnancy
  • Absence of
  • to FEES as determined by the treating physician (e.g., high bleeding risk or severe oxygen requirements)
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
274 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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)

Interventions

  • Diagnostic testFiberoptic 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Aspiration Pneumonia

    Incidence of aspiration pneumonia following extubation

    Time frame: Up to 30 days after extubation

  3. Reintubation

    Need for reintubation after extubation

    Time frame: Up to 30 days after extubation

  4. Ventilator-Free Days

    Number of ventilator-free days after extubation

    Time frame: 28 days

  5. ICU Length of Stay

    Length of ICU stay after extubation

    Time frame: Up to 24 weeks

  6. Hospital length of stay

    Total hospital length of stay

    Time frame: Up to 26 weeks

  7. ICU Mortality

    Death occurring during ICU stay

    Time frame: Up to 24 weeks

  8. Hospital Mortality

    Death occurring during hospitalization

    Time frame: Up to 26 weeks

  9. Risk Factors Associated With Silent Aspiration

    Clinical factors independently associated with silent aspiration identified using multivariable analysis

    Time frame: Up to 26 weeks

  10. Duration of Dysphagia

    Duration of post-extubation dysphagia identified by FEES

    Time frame: Up to 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07635888
Lead sponsor
Cleveland Clinic Abu Dhabi
Responsible party
Jihad Mallat (Critical Care Consultant, Cleveland Clinic Abu Dhabi) — Principal investigator
First posted
Jun 9, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Jun 9, 2026

Study contacts

Jihad Mallat, MD, PhD
Contact
mallatj@ccad.ae
+97125019000
Jihad Mallat, MD, PhD
principal investigator · Cleveland Clinic Abu Dhabi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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