Silent Aspiration Following Extubation in the ICU

NCT07635888 | Not Yet Recruiting

• 1 other identifier: A-2026-026
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

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.

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; Critical care; Dysphagia screening

Outcome Measures

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

  Up to 72 hours after extubation

Secondary Outcomes (10)

• Diagnostic Accuracy of Bedside Swallow Screening

  Up to 72 hours after extubation

• Aspiration Pneumonia

  Up to 30 days after extubation

• Reintubation

  Up to 30 days after extubation

• Ventilator-Free Days

  28 days

• ICU Length of Stay

  Up to 24 weeks

Study Arms (1)

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

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.

ICU Patients Following Prolonged Mechanical Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cleveland Clinic Abu Dhabi: lead

Study Sites (1)

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

Location

MeSH Terms

Conditions

Deglutition Disorders; Critical Illness; Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jihad Mallat, MD, PhD

  Cleveland Clinic Abu Dhabi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihad Mallat, MD, PhD

CONTACT

+97125019000; mallatj@ccad.ae

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical Care Consultant

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

AE (1)