Silent AspirationSAFE-ICUNCT07635888
Silent Aspiration Following Extubation in the ICU
An observational study of Silent Aspiration and Post-Extubation Dysphagia, run by Cleveland Clinic Abu Dhabi at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Silent Aspiration, Post-Extubation Dysphagia, Deglutition Disorders
- What is being tested?
- Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
- How many people
- 274 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Jun 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site
Cleveland Clinic Abu Dhabi
Abu Dhabi
Jihad Mallat, MD PhD, +97125019000, mallatj@ccad.ae
About this study
Official title: 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.
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).
- Conditions
- Silent Aspiration, Post-Extubation Dysphagia, Deglutition Disorders, Critical Illness, Mechanical Ventilation Complication
- Being tested
- Fiberoptic Endoscopic Evaluation of Swallowing (FEES)
- Keywords
- Silent aspiration, ICU extubation, Post-extubation dysphagia, FEES, Fiberoptic Endoscopic Evaluation of Swallowing, Mechanical ventilation, Swallow screening, Aspiration pneumonia, Critical care, Dysphagia screening
- Medical subject headings
- Deglutition Disorders, Critical Illness, Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing (FEES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 72 hours after extubation
Secondary outcomes (10)
Diagnostic Accuracy of Bedside Swallow Screening
Sensitivity and specificity of bedside nursing swallow screening for detecting silent aspiration using FEES as the reference standard
Measured: Up to 72 hours after extubation
Aspiration Pneumonia
Incidence of aspiration pneumonia following extubation
Measured: Up to 30 days after extubation
Reintubation
Need for reintubation after extubation
Measured: Up to 30 days after extubation
Ventilator-Free Days
Number of ventilator-free days after extubation
Measured: 28 days
ICU Length of Stay
Length of ICU stay after extubation
Measured: Up to 24 weeks
Hospital length of stay
Total hospital length of stay
Measured: Up to 26 weeks
ICU Mortality
Death occurring during ICU stay
Measured: Up to 24 weeks
Hospital Mortality
Death occurring during hospitalization
Measured: Up to 26 weeks
Risk Factors Associated With Silent Aspiration
Clinical factors independently associated with silent aspiration identified using multivariable analysis
Measured: Up to 26 weeks
Duration of Dysphagia
Duration of post-extubation dysphagia identified by FEES
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silent AspirationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Abu Dhabi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihad Mallat, Cleveland Clinic Abu Dhabi
- Investigators
- Jihad Mallat, MD, PhD, Principal investigator, Cleveland Clinic Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635888
- Sponsor's protocol ID
- A-2026-026
- Acronym
- SAFE-ICU
- Status last verified
- May 2026
- First submitted
- 17 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors, and Outcomes of Silent Aspiration Post Extubation in the ICU
- ClinicalTrials.gov ID
- NCT07635888
- Acronym / sponsor ID
- SAFE-ICU / A-2026-026
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Cleveland Clinic Abu DhabiUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patients Following Prolonged Mechanical Ventilation | – | Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing (FEES)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | ICU Patients Following Prolonged Mechanical Ventilation |
Primary outcome
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
10 secondary outcomes
Diagnostic Accuracy of Bedside Swallow Screening
Time frame: Up to 72 hours after extubation
Aspiration Pneumonia
Time frame: Up to 30 days after extubation
Reintubation
Time frame: Up to 30 days after extubation
Ventilator-Free Days
Time frame: 28 days
ICU Length of Stay
Time frame: Up to 24 weeks
Hospital length of stay
Time frame: Up to 26 weeks
ICU Mortality
Time frame: Up to 24 weeks
Hospital Mortality
Time frame: Up to 26 weeks
Risk Factors Associated With Silent Aspiration
Time frame: Up to 26 weeks
Duration of Dysphagia
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jihad Mallat, MD, PhD principal investigator
Cleveland Clinic Abu Dhabi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Silent Aspiration and Post-Extubation Dysphagia, run by Cleveland Clinic Abu Dhabi at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihad Mallat, MD, PhD (+97125019000, mallatj@ccad.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Silent Aspiration After Extubation (time frame: Up to 72 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.